rock%lighthouse%pyrdc%wubios@uunet.UU.NET (Roger Rock Rosner) (10/28/89)
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TREATMENT - Table of Contents December 1988 - Vol 1, No 1
Anti-retroviral and AZT Protocols
AZT & Alpha Interferon
AZT for Veterans
AZT in Early ARC (ATEU 016)
Chemotherapy and Azidothymidine (AZT) with or without radiotherapy
(ATEU 008)
Chemotherapy, Radiotherapy and AZT for AIDS-related primary central
nervous system (CNS) lymphoma (ATEU 009)
ddI (2',3'-dideoxyinosine)
Oral Dextran Sulfate (ACTG 060)
Recombinant Soluble CD4
Pneumocystis Carinni Pneumonia (PCP) Protocols
Aerosolized Pentamidine for Single Episode of PCP
Aerosolized Pentamidine for Multiple Episodes of PCP for Veterans
Miscellaneous Protocols
Aerosolized Gamma-Interferon
Blood Drawing Study
Bronchoalveolar Lavage Study
gp-160 (Vaccine)
Other Protocols
Anti-Retroviral and AZT-related Protocols
Cytomegalovirus (CMV) Colitis Protocols
Cytomegalovirus (CMV) Retinitis Protocols
K.S. Protocols
Pneumocystis Carinii Pneumonia Protocols
Miscellaneous
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ANTI-RETROVIRAL AND AZT PROTOCOLS
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AZT & ALPHA INTERFERON
DESCRIPTION: Study of AZT alone vs. AZT and Alpha Interferon vs. Alpha
Interferon alone, for people in the early stages of HIV infection.
REQUIREMENTS: Positive lymphocyte culture for HIV, or positive p24 antigen
test, or positive PCR test, and T4 cell counts of more than 500 per cubic
millimeter. Participants must be over age 18, have not participated
previously in any other HIV protocols, have good veins, and be willing to
come to NIH for weekly to biweekly blood drawing and clinic visits.
Participants must also have a private physician involved in their care and
available for communication with the NIH doctors and nurses during the time
they are on this study.
TERM: Indefinite. The study continues until the participant develops an
opportunistic infection, their T4 cell counts drop below 200, or the
participant develops severe side-effects or reactions (toxicity) to either
of the medications.
ADMINISTRATION: Participants will be divided into three groups: one will
receive AZT alone, one will receive AZT and alpha interferon, and the last
will receive alpha interferon alone. AZT is given orally; alpha interferon
is given by injection. Persons enrolled in the study will be taught to give
the alpha interferon to themselves. The AZT-only group will take 200 mg
every four hours. The AZT/alpha interferon group will take 100 mg of AZT
every 4 hours and 1 million units of alpha interferon every day. The alpha
interferon-only group will initially receive 5 million units every day. The
doses of alpha interferon will be increased, as tolerated, to a maximum of
35 million units per day.
METHODOLOGY: AZT is a "nucleoside analog" (a fake version of the base
thymidine) which interferes with the ability of HIV to make copies of itself
(see "A Layman's Guide to HIV," in this issue). Alpha Interferon interferes
with the final assembly process of HIV which happens as HIV tries to bud off
new copies of itself into the bloodstream.
NOTES: Potential side effects of AZT include nausea, headaches, fatigue,
and anemia that may require blood transfusion. Alpha interferon can cause
flu-like symptoms (fevers, fatigue, muscle aches, decrease in appetite), a
decrease in white blood cell count, and mental changes, including
depression, memory loss, and difficulty concentrating.
CONTROLS: None.
ORGANIZATION: National Institutes of Health/National Institute of Allergy
and Infectious Diseases (NIAID), Laboratory of Immunoregulation.
CONTACT: Victoria Davey, Building 10, Room 11B09, National Institutes of
Health, Bethesda, MD 20892 (Medical Center METRO stop). (301) 496-7196.
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AZT FOR VETERANS
DESCRIPTION: Study of the effectiveness of AZT in a double-blind, placebo
controlled study of patients with ARC (AIDS Related Complex).
REQUIREMENTS: Participants in the study must be VA eligible. They must be
HIV antibody positive, with T-cell counts between 200 and 500, and they must
have some minor symptoms.
TERM: The protocol lasts for three years.
ADMINISTRATION: The study drug is taken orally in 250 mg doses every four
hours, around the clock.
METHODOLOGY: AZT is a Chain Terminator (see the "Layman's Guide to HIV," in
this issue). This study attempts to determine to what extent AZT helps
people with ARC.
CONTROLS: This is a double-blind, randomized, placebo-controlled study.
This means that 50% of the participants will get AZT, and there is a 50%
chance that they will not. No one (neither the researchers nor the patient)
will know who is on the placebo and who is on AZT.
ORGANIZATION: Veterans Administration Hospital Medical Center.
CONTACT: Mary Elena Seiler, (202) 745-8694; or Megan Wholey, (202) 745-
8694.
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AZT IN EARLY ARC (ATEU 016)
DESCRIPTION: This study will test the long-term effects of AZT on people
with early AIDS-related complex.
REQUIREMENTS: You must have early AIDS-related complex; have a CD-4 cell
count between 800 and 200; be positive on the ELISA test; have the ability
to carry on normal activity (even with effort); have only some or no signs
of symptoms of disease; pass certain laboratory parameters; and be able to
give informed consent. (There are infections which might exclude you from
this study, most of which are opportunistic infections fulfilling the
definition of full-blown AIDS.) If you are less than 18 years old, you must
have written consent of a parent or guardian. Women of child-bearing
potential must practice abstinence or birth control and have a negative
pregnancy test within 30 days of entry into the study.
TERM: The treatment period will last a minimum of 104 weeks beyond the
accrual of the last patient.
ADMINISTRATION: You will undergo pretreatment and follow-up histories,
physical examinations and laboratory studies. The clinic will obtain from
you immunologic serum studies for antigen and antibody level studies
performed throughout the protocol. Subjects will be randomly assigned to
receive either Zidovudine (AZT) or a placebo dispensed on a biweekly basis
for the first 16 weeks of the study and every month thereafter. The
Zidovudine or placebo will be administered by mouth every four hours
throughout the day. You will be required to visit the clinic every two
weeks during the first 16 weeks of the study, and monthly thereafter.
METHODOLOGY: Zidovudine (other names are Retrovir and AZT) has been proven
in the laboratory to slow or stop the growth of the AIDS virus. AZT has
been shown to be effective in a certain group of subjects with advanced
AIDS-related complex (ARC) in a recently completed test. Overall findings
of the study demonstrated that AZT decreased the incidence and severity of
opportunistic infections resulting in prolonged life compared to subjects
not receiving AZT. In particular, subjects with AIDS-related complex
receiving AZT did not develop opportunistic infections (AIDS) after only six
weeks of therapy. These data suggest that AZT is not only beneficial in
subjects with AIDS, but may have a broader value in delaying the progression
of symptoms and disease in subject with earlier or milder forms of HIV
infection.
NOTES: Because this is a placebo-controlled study, THERE IS A 50/50 RANDOM
CHANCE THAT YOU WILL NOT RECEIVE AZT. It is significant that subjects with
more severe symptoms or with T-helper cells less than 200 experienced the
greatest side effects. Possible side effects from AZT include: headache,
muscle aches, nausea, vomiting, anemia or lowering of the white blood cell
count and platelet count.
CONTROLS: Randomized double-blind placebo controlled trial. This means
that neither the patient nor the researchers will know who is receiving
Zidovudine or the placebo.
ORGANIZATION: George Washington University, one of the AIDS Treatment
Evaluation Units (ATEUs) run by NIH.
CONTACT: Jane Courtless, R.N., George Washington University. (202) 994-
2417.
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CHEMOTHERAPY AND AZIDOTHYMIDINE (AZT) WITH OR WITHOUT RADIOTHERAPY (ATEU
008)
DESCRIPTION: Treatment for high grade lymphoma in AIDS-risk group members.
REQUIREMENTS: You must be an AIDS patient between the ages of 18 and 70
with a pathological diagnosis of lymphoma (untreated). Your kidney, liver
and bone marrow function must be "adequate." If you are a woman with child-
bearing potential, you must have a negative pregnancy test within 14 days
from the start of the study and agree to abstain from heterosexual sex or to
employ appropriate birth control for the duration of the study. If you are
currently on AZT, it will be discontinued two weeks before beginning the
study, and restored after chemotherapy is completed.
TERM: Four to 18 months, depending on your response to treatment.
ADMINISTRATION: Within the first eight days of the study you will be given
a complete physical examination. This exam will include chest X-ray, CAT
scans, bone marrow test, spinal tap, pulmonary function tests, blood test,
stool culture, urinalysis and neurological testing.
Treatment consists of four to six months of chemotherapy treatment with the
possibility of concurrent radiation therapy, followed by a year's supply of
AZT.
The chemotherapy will consist of administration of dosages of several drugs
intended to eliminate existing tumors and to prevent new tumor growth. The
cycles of these chemotherapy treatments will occur at three to four week
intervals. Normally there will be a maximum of six cycles of chemotherapy.
However, if during the course of treatment you show a complete remission of
the lymphoma, you will receive two additional cycles of chemotherapy beyond
the cycle in which your remission is documented.
AZT therapy will begin and continue for 52 weeks after the chemotherapy
cycles are completed. Additional physical examinations and testing will
occur periodically during the course of the treatment.
METHODOLOGY: This study is being done to determine the toxicity of high
dose chemotherapy and/or radiation when administered in conjunction with
AZT. It might result in medical scientists determining whether they can
successfully effect a remission of B-cell lymphoma while inhibiting HIV
replication.
CONTROLS: None.
ORGANIZATION: George Washington University, one of the AIDS Treatment
Evaluation Units (ATEUs) run by NIH.
CONTACT: Jane Courtless, R.N., George Washington University. (202) 994-
2417.
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CHEMOTHERAPY, RADIOTHERAPY AND AZT FOR AIDS-RELATED PRIMARY CENTRAL NERVOUS
SYSTEM (CNS) LYMPHOMA (ATEU 009)
DESCRIPTION: Testing the safety and toxicity of chemotherapy, radiation and
AZT on AIDS patients with central nervous system lymphoma.
REQUIREMENTS: You must be between 18 and 70 years old, be HIV infected and
have newly diagnosed and previously untreated central nervous system
lymphoma. You must have adequate liver, kidney and bone marrow function.
You must be free of active tumors (except skin cancers and Kaposi's sarcoma)
outside the central nervous system. You must not have taken an
immunomodulator or an antiretroviral agent other than AZT within 14 days of
the beginning of this study. You cannot have taken any experimental drug
within 30 days of the study. You must not require treatment with
corticosteroids or non-steroidal anti-inflammatory drugs.
If you are a woman with child-bearing potential, you must have a negative
pregnancy test within 14 days from the start of the study and agree to
abstain from sex or to employ appropriate birth control for the duration of
the study.
TERM: Two to 12 months, depending on your response to the treatment.
ADMINISTRATION: At the beginning of the study you will be given a complete
physical examination and many tests to assess your health status. These
tests include blood work, urinalysis, pulmonary function, bone marrow, chest
X-ray, and CAT scans. They may also include an EKG and spinal tap. A
pathological diagnosis of lymphoma is required.
You will receive AZT five times a day every day for one year beginning with
the first day of the study. Radiation treatments to the head will be given
to you five days a week for approximately four weeks. In addition, you will
be given chemotherapy which consists of medicines which are traditional (not
experimental) in the treatment of lymphoma. They will include high doses of
methotrexate and dexamethasone (Decadron).
The dexamethasone will be given by mouth for approximately two weeks when
the radiation treatment is first begun. The methotrexate will be given by
vein once each week for four weeks when the radiation has been completed.
Another drug, leucovorin, will be given to reduce the potential toxicity of
methotrexate on your bone marrow. This treatment will require you to go to
the hospital for one or two days a week for four weeks.
On four occasions during the course of the treatment, you will undergo a
brain scan and spinal tap to determine your response to the treatments.
METHODOLOGY: Experience has shown that AIDS patients are at higher than
normal risk for developing central nervous system lymphoma. Although the
mechanism involved is still a mystery, many AIDS patients who have been
successfully treated with radiation and/or chemotherapy tend to show a
recurrence of the lymphoma. The medical scientists believe that your immune
system dysfunction, caused by the HIV infection, is what makes you a
candidate for the recurrence. This combination treatment involving AZT
along with the radiation and chemotherapy is intended to protect your immune
system while treating the lymphoma. It is hoped that the addition of AZT to
the traditional treatment for lymphoma might improve your chances of
preventing a recurrence if the chemotherapy and radiation are successful in
creating a remission of the lymphoma.
CONTROLS: None. All those entered in the study will receive actual
treatments. No one will receive a placebo.
ORGANIZATION: George Washington University, one of the AIDS Treatment
Evaluation Units (ATEUs) run by NIH.
CONTACT: Jane Courtless, R.N., George Washington University. (202) 994-
2417.
----------------------------------
ddI (2',3'-DIDEOXYINOSINE)
DESCRIPTION: Phase I Study of drug to fight HIV.
REQUIREMENTS: This study is for people with AIDS or severe ARC,
PARTICULARLY PEOPLE WHO HAVE NOT BEEN ON AZT OR HAVE BEEN ON AZT FOR SIX
WEEKS OR LESS. Participants must be off AZT and other anti-viral therapy
for at least four weeks before the study. All participants must have a
count of less than 350 T4 cells per ml, and must not be anemic or have a low
white blood count. ARC patients must have either oral thrush or weight
loss. People with severe Kaposi's sarcoma or active opportunistic
infections are excluded.
TERM: The initial phase lasts for a total of six weeks; two as an inpatient
and four as an outpatient. If the initial results prove favorable, it is
possible that permission will be obtained from the FDA to continue the study
for a longer period of time.
ADMINISTRATION: On the first day, the drug will be given once
intravenously; on the second day, the drug will be given once orally; and
for the remainder of the (two week) inpatient period, the drug will be given
intravenously two or three times a day. The volunteer will then take the
drug by mouth two or three times a day as an outpatient for four weeks. The
volunteer will be required to return to NIH once a week for monitoring.
After the initial study period it is possible that NIH will get permission
from the FDA to continue testing the drug for a longer period. However,
with a Phase I Study, everything is very much up in the air and subject to
negotiation and changes as the study progresses. If the Phase I study of
ddI is not continued, patients can either be transferred to other treatment
protocols, or drop out, at their option.
METHODOLOGY: ddI is a Chain Terminator (see "A Layman's Guide to HIV" in
this newsletter). ddI changes in your body to an activated form of ddA, a
"fake" version of adenosine which doesn't let anything else chain onto it.
This means that when HIV tries to replicate itself by copying its RNA to
DNA, the "fake" ddA gets added to the DNA strand instead of real adenosine.
ddA doesn't have the necessary "hooks" for the next compound in the chain to
link into. The DNA strand just stops, halted in its tracks, incomplete and
ineffective. ddI is handled by the body differently than AZT, and it
appears to be less toxic for bone-marrow cells than AZT (in the test tube).
NOTES: Preliminary results with another form of this drug, ddA, indicated
that, at the doses tested, it could be tolerated for up to eight weeks
without major side effects (toxicity problems). Some patients on ddA had
increases in their T4 cell counts. ddA is converted in the body to ddI, and
as mentioned above, ddI is converted back again to an activated form of ddA,
so it is likely that similar therapeutic results will be obtained with ddI.
The doses that will be tested in this study are similar to the doses that
have already been tested with ddA.
CONTROLS: None. (In a Phase I study, all patients receive the actual
drug.)
ORGANIZATION: National Institutes of Health/National Cancer Institute
CONTACT: Dr. Robert Yarchoan, Building 10, Room 12N214, National Institutes
of Health, Bethesda, MD 20892 (Medical Center METRO stop). (301) 496-0328
----------------------------------
ORAL DEXTRAN SULFATE (ACTG 060)
DESCRIPTION: Phase I/II study of a drug to fight HIV.
REQUIREMENTS: There are three groups of patients: HIV positive, ARC, and
AIDS. All must have a positive response to the p24 antigen test and the
ELISA HIV-antibody test. Patient must be relatively self-sufficient (not
requiring considerable assistance or frequent medical care). T4 counts must
be less than 600 per cubic millimeter. Men and women of child-bearing
potential must employ abstinence or a barrier method of contraception while
in the study. Women must have a negative pregnancy test within one month of
the start of the study. The following people are excluded: children less
than 12 years old; pregnant women and nursing mothers; anyone treated with
AZT or any other anti-retroviral drugs within the preceding four weeks;
anyone previously treated with dextran sulfate; anyone receiving ribavirin
within the preceding 12 weeks; anyone receiving any other investigational
drugs within the preceding four weeks; patients with active opportunistic
infections; patients treated with anticoagulant drugs; patients with severe
diarrhea; anyone with severe (greater than 10%) weight loss within the past
three months; and anyone with active alcohol or drug abuse. There are also
certain laboratory tests involving blood chemistry that participants must
pass.
TERM: 28 weeks: 24 weeks on the study, and a four week follow-up, with a
possibility of remaining on the drug until the study results are evaluated
if a patient responded favorably to it.
ADMINISTRATION: The drug will be taken by mouth, between meals, three times
a day (at as close to 10 a.m., 4 p.m., and before bed as possible).
Participants must not take Dextran Sulfate with food. The participants will
be divided into different groups receiving increasing dosages as the study
progresses.
METHODOLOGY: Dextran Sulfate has been used orally in Japan for the past 20
years to help control the levels of certain fats in the blood. It has also
been used intravenously as an anticoagulant. In the laboratory, Dextran
Sulfate has shown an ability to fight HIV in several ways: it has a modest
effect on the ability of HIV to replicate (acting as a Chain Terminator,
like AZT), and it also seems to inhibit the ability of HIV to infect cells,
and to block the formation of syncytia (binding of cells into one big,
useless clump) and the bursting of cells.
NOTES: Patients will need to be evaluated biweekly for the first two
months, and monthly thereafter. Aspirin, sedatives, barbiturates, steroids
and other medications are expressly prohibited due to possible dangerous
interactions. Use of other medications is allowed with the investigator's
permission.
Possible side effects include mental hyperactivity, gastrointestinal
problems; and the possibility of a mild skin rash. Patients experiencing
mild side effects may have their dosage reduced; patients who have severe
side effects will no longer receive Dextran Sulfate.
CONTROLS: None. In a Phase I study all patients receive the drug.
ORGANIZATION: George Washington University, one of the AIDS Treatment
Evaluation Units (ATEUs) run by NIH.
CONTACT: Jane Courtless, R.N., George Washington University. (202) 994-
2417.
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RECOMBINANT SOLUBLE CD4
DESCRIPTION: Phase I study of the effectiveness of Recombinant Soluble CD4
in patients with AIDS/ARC.
REQUIREMENTS: This study is for people with AIDS who have had one
opportunistic infection, or symptomatic ARC patients. The study is
particularly for people WHO HAVE NOT BEEN ON AZT OR HAVE BEEN ON AZT FOR SIX
WEEKS OR LESS. Participants must be off AZT and other anti-viral therapy
for at least four weeks before the study. All participants must have a
count of less than 400 T4 cells per ml.
TERM: The study lasts for two and a half weeks, all of which is in-patient
at the NIH Clinical Center. The possibility exists for an extension to six
months, if the participant shows a positive response.
ADMINISTRATION: The drug will be administered by a continuous infusion
through an IV.
METHODOLOGY: The CD4 receptors on the surface of your T4 cells are the
places that HIV attaches to when it binds to and attacks your T4 cells.
Recombinant Soluble CD4 is like the attachment points without the T4 cells
underneath it. It is hoped that HIV will attach to the CD4 on the R.S. CD4
instead of on your actual T4 cells, and since R.S. CD4 is not attached to a
real T4 cell, and is thus useless to HIV (because it is not a real T4 cell,
and thus cannot be taken over and used by HIV to hide and to replicate
itself), that HIV will thus be rendered ineffective and unable to replicate.
NOTES: Preliminary studies revealed no apparent side effects (no toxicity
problems). There is currently a long waiting list to get onto the CD4
protocol.
CONTROLS: None. (In a Phase I study, all patients receive the actual
drug.)
ORGANIZATION: National Institutes of Health/National Cancer Institute
CONTACT: Dr. Robert Yarchoan, Building 10, Room 12N214, National Institutes
of Health, Bethesda, MD 20892 (Medical Center METRO stop). (301) 496-0328
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PNEUMOCYSTIC CARINII PNEUMONIA PROTOCOLS
-----------------------------------------
AEROSOLIZED PENTAMIDINE FOR SINGLE EPISODE OF PCP
DESCRIPTION: Study of the effectiveness of aerosolized Pentamidine as
prophylaxis against Pneumocystis Carinii Pneumonia (PCP) in patients who
have had one previous episode of PCP.
REQUIREMENTS: Open to anyone who has had an episode of PCP in the last six
months. The PCP must have been proven by bronchoscopy.
TERM: Indeterminate.
ADMINISTRATION: Participants will receive medication once every two weeks
following administration of five loading doses (loading doses are five doses
of medication given anywhere from 24 to 72 hours apart). Patients will be
randomly assigned to a dosage group, receiving either 5 mg, 60 mg, or 120 mg
per dose. The treatments are given at the VA hospital for veterans and at
Washington Hospital Center for non-veterans.
METHODOLOGY: Aerosolized Pentamidine has been shown to be effective as a
treatment for PCP. This study will attempt to determine if aerosolized
pentamidine protects against recurrence of pneumocystis carinii pneumonia.
CONTROLS: None. All participants will receive aerosolized pentamidine at
some dosage level.
ORGANIZATION: Veterans Administration Hospital Medical Center.
CONTACT: Mary Elena Seiler, (202) 745-8694.
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AEROSOLIZED PENTAMIDINE FOR MULTIPLE EPISODES OF PCP FOR VETERANS
DESCRIPTION: Study of the effectiveness of aerosolized Pentamidine as
prophylaxis against Pneumocystis Carinii Pneumonia (PCP) in patients who
have had multiple episodes of PCP.
REQUIREMENTS: Participants in the study must be VA eligible. Participants
must have had more than one episode of PCP. At least one episode of PCP
must have been proven by bronchoscopy. The other episodes only need a
clinical diagnosis.
TERM: Indeterminate.
ADMINISTRATION: Participants will receive medication once every two weeks
following administration of five loading doses (loading doses are five doses
of medication given anywhere from 24 to 72 hours apart). Patients will be
randomly assigned to a dosage group, receiving either 60 mg or 120 mg per
dose. Treatments will be given at the VA hospital.
METHODOLOGY: Aerosolized Pentamidine has been shown to be effective as a
treatment for PCP. This study will attempt to determine if aerosolized
pentamidine protects against recurrence of pneumocystis carinii pneumonia.
CONTROLS: None. All participants will receive aerosolized pentamidine at
some dosage level.
ORGANIZATION: Veterans Administration Hospital Medical Center.
CONTACT: Megan Wholey, (202) 745-8694.
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MISCELLANEOUS PROTOCOLS
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AEROSOLIZED GAMMA-INTERFERON
DESCRIPTION: Study to assess the effect of aerosolized recombinant human
interferon-gamma on lung defense mechanisms.
REQUIREMENTS: Patients must be between the ages of 18 and 50, be positive
for antibodies to HIV, and do not have pulmonary opportunistic infections
(e.g. Pneumocystis Carinii Pneumonia or other lungs disorders) or Kaposi's
sarcoma.
TERM: There are two parts to the study. Together, they require a total of
15 days over approximately two two-week periods, as an in-patient at the NIH
Clinical Center. The two week periods may be separated in time and
participants will be able to leave during the day and at night at times when
studies are not being carried out.
ADMINISTRATION: The first part of the study is an acute toxicity study to
determine if there are serious hazards to the administration of aerosolized
gamma-interferon. During this phase of the study, four increasing doses of
recombinant gamma-interferon will be administered by aerosol over a 10 day
period. The second part is a bioavailability study to determine the amount
of gamma-interferon in the lungs after it is administered, and its effects
on the anti-microorganism activity of lung macrophages. For this phase,
patients will receive daily aerosol treatments of gamma-interferon for one
week at the maximum tolerated dose. Gamma-interferon will be administered
by aerosol; a spray form of the medication will be created by placing liquid
gamma-interferon in a device that generates a fine mist containing tiny
droplets of gamma-interferon, which can then be inhaled.
COMPENSATION: Participants in the study will receive compensation of
$586.00 for the first part of the study, and $748.00 for the second part of
the study, for a total of $1,334.00.
METHODOLOGY: Gamma-interferon is a protein naturally produced by cells of
the immune system that activates lung macrophages, which are cells that play
a key role in lung defense mechanisms against microorganisms.
NOTES: Before receiving the recombinant gamma-interferon, patients will
have a thorough medical evaluation including a medical history, physical
examination, chest X-rays, lung function studies, electrocardiogram, blood
tests, urine tests, gallium scan and bronchoscopy. In addition, patients
will be asked to undergo bronchoscopy with lung washings to determine how
much aerosolized recombinant gamma-interferon has been deposited into the
lungs and whether it is able to function to activate lung macrophages
against infections.
CONTROLS: None. All participants will receive actual recombinant gamma-
interferon.
ORGANIZATION: National Institutes of Health/National Heart, Lung, and Blood
Institute, Bethesda, MD 20892
CONTACT: Pulmonary Branch, (301) 496-2449.
----------------------------------
BLOOD DRAWING STUDY
DESCRIPTION: Blood is drawn for research on the immune response to the AIDS
virus.
REQUIREMENTS: Patients must be positive for antibodies to HIV-1, without
severe anemia. Medication usage is acceptable.
TERM: Several hours as an out-patient at the NIH Clinical Center.
ADMINISTRATION: One unit of blood is drawn, the same amount that would be
given when donating blood for transfusion.
COMPENSATION: Participants in the study will receive compensation of
$30.00.
METHODOLOGY: The blood drawn will be used in research to fight HIV.
CONTROLS: Not applicable.
ORGANIZATION: National Institutes of Health/National Heart, Lung, and Blood
Institute/Pulmonary Branch, Bethesda, MD 20892
CONTACT: Pulmonary Branch, (301) 496-2449.
----------------------------------
BRONCHOALVEOLAR LAVAGE STUDY
DESCRIPTION: Study to assess the impact of HIV-1 infection on lung defense
mechanisms.
REQUIREMENTS: Patients must be between the ages of 18 and 60, be positive
for antibodies to HIV, and not had active pulmonary opportunistic infections
(e.g. Pneumocystis Carinii Pneumonia or other lungs disorders) in the last
three months. Infection prior to three months, current medication use or
Kaposi's sarcoma are not exclusions.
TERM: The study involves one full day as an in-patient at the NIH Clinical
Center.
ADMINISTRATION: Participants will receive a complete medical evaluation
including a medical history, physical examination, chest X-rays,
electrocardiogram, urinalysis, blood tests, lung function studies, and
bronchoscopy with washes for analysis of cells and potential pneumonias.
COMPENSATION: Participants in the study will receive compensation of
$122.00.
METHODOLOGY: Analysis will be made of the washes of the lungs so
researchers can gather more information on what organisms attack the lungs,
and how the lungs' defense mechanisms operate.
NOTES: No prescriptions are dispensed. Results of testing are made
available to the participant and a referring physician.
CONTROLS: Not applicable.
ORGANIZATION: National Institutes of Health/National Heart, Lung, and Blood
Institute/Pulmonary Branch, Bethesda, MD 20892
CONTACT: Pulmonary Branch, (301) 496-2449.
----------------------------------
gp-160
DESCRIPTION: Experimental vaccine against HIV
REQUIREMENTS: You must be male, negative (non-reactive) on the ELISA test
for antibodies to HIV, and have had no unsafe sex for at least three months
prior to the screening. Participants cannot be promiscuous or in a sexual
relationship with an HIV-positive partner. A commitment is required not to
have sex which will place you at risk for HIV infection (either oral or
anal, with or without condoms) for at least three months following
vaccination (a year is desired).
TERM: Approximately 13 months.
ADMINISTRATION: Initial screening, blood work, and a tetanus/diptheria
booster shot for people who aren't current; followed by an intensive
physical examination four weeks later; then administration of the vaccine
by intramuscular injection. Required follow-up visits once a week for four
weeks, then once a month for the next year.
METHODOLOGY: gp-160 is the protein that forms the protein coat of HIV.
This vaccination is NOT a "dead" virus, so there is zero chance of HIV
infection from the vaccine. gp-160 is synthesized using recombinant DNA
techniques (gene splicing). The hope is that your body will respond to the
protein and form antibodies to it (just like any other vaccine). One result
of this is that if the vaccine works, volunteers will then test positive for
HIV antibodies on the ELISA test. The more sophisticated Western Blot test,
done by a competent laboratory, should be able to tell the difference
between HIV infection and antibodies formed in response to gp-160.
Volunteers will get notarized copies of their Western Blot tests before and
after participation in the study, as well as a detailed description. Be
warned, however, that insurance companies (both health and life) may still
discriminate against you because of testing positive for HIV antibodies, and
other problems could arise with regard to employment in the military, or the
State Department, etc.
NOTES: Because the study relies on the Western Blot test to make sure that
individuals do not have HIV before the study begins, 50% of the volunteers
have been rejected after the initial screening (because of problems in
getting a clear Western Blot test). The researchers think that this may be
because the Western Blot test is too sensitive, and is reacting to non-HIV
proteins. Until something can be proved, they are rejecting anyone who does
not have a completely clear Western Blot.
CONTROLS: Very few. One fifth of the volunteers at the highest dosage
levels will get a harmless substance called KLH as a control group to see
how their immune response differs from the immune response of the volunteers
getting gp-160. But, basically, almost all of the volunteers get the actual
vaccine.
ORGANIZATION: National Institutes of Health/National Institute of Allergy
and Infectious Diseases (NIAID).
CONTACT: Margaret Easter, Building 10, Room 11B-13, National Institutes of
Health, Bethesda, MD 20892 (Medical Center METRO stop). (301) 496-7196.
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OTHER PROTOCOLS
The following is a list of protocols, compiled by the staff of the Whitman-
Walker Clinic, of other protocols available in the Washington area. THIS
LIST HAS ***NOT*** BEEN VERIFIED BY THE WASHINGTON HIV NEWS. Future issues
of Washington HIV News will carry more in-depth descriptions of these
protocols.
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ANTI-RETROVIRAL AND AZT-RELATED PROTOCOLS
Alpha Interferon
National Institutes of Health/National Institutes of Allergy and Infectious
Diseases, Victoria Davey. (301) 496-7196.
Alpha-interferon + Interleukin-2: Phase I Dosage Study
National Institutes of Health/National Institutes of Allergy and Infectious
Diseases. (301) 496-7196.
Alternating recombinant human GM-CSF and AZT in persons with HIV infection
and leukopenia
National Institutes of Health/National Cancer Institute, Dr. Samuel Broder.
(301) 496-4251.
AZT: HIV Antibody Positive and/or lymphadenopathy
George Washington University. (202) 994-2417.
AZT in Asymptomatic HIV Positive patients: double blind placebo controlled
George Washington University. (202) 994-2417.
AZT with bone marrow transplant and peripheral lymphocyte transfers
National Institutes of Health/National Institutes of Allergy and Infectious
Diseases, Margaret Easter. (301) 496-7196.
AZT for Asymptomatic HIV Positive: Double blind placebo controlled
Whitman-Walker Clinic, Dr. Basil Vareldzis. (202) 797-3534.
Betaseron + AZT in HIV Positive, ARC, & AIDS: double blind placebo
controlled
George Washington University. (202) 994-2417.
Effect of AZT on HIV associated neurological and/or neuromuscular
dysfunction
National Institutes of Health/National Institute of Mental Health, Valita
Fredland. (301) 496-2429.
Efficacy of B12/Folate for patients on AZT
Georgetown University, Dr. Mary Young. (202) 687-8672.
Neuropsychiatric changes accompanying Alpha Interferon therapy in treatment
of HIV viremia
National Institutes of Health/National Institute of Mental Health, Dr. Mark
Dimitrack. (301) 496-6565.
Neuropsychiatric characterization of HIV Antibody Positive persons on AZT
Georgetown University, Pim Brouwers. (202) 687-4954.
Recombinant Erythopoeitin in AIDS patients with anemia: double blind
placebo controlled
George Washington University. (202) 994-2417.
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CYTOMEGALOVIRUS (CMV) COLITIS PROTOCOLS
DHPG (Ganciclovir)
National Institutes of Health/National Institutes of Allergy and Infectious
Diseases, Margaret Easter. (301) 496-7196.
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CYTOMEGALOVIRUS (CMV) RETINITIS PROTOCOLS
Foscarnet for CMV Retinitis
National Institutes of Health/National Eye Institute, Dr. Robert
Nussenblatt. (301) 496-3123.
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K.S. PROTOCOLS
Doxorubicin (Adriamycin): AIDS-Associated Kaposi's Sarcoma (K.S.)
George Washington University. (202) 994-2417.
Interleukin-2 and AZT: Phase I Dosage Study
National Institutes of Health/National Institutes of Allergy and Infectious
Diseases, Dianne Lee. (301) 496-7196.
Muramyl Tripeptide: Phase I Open Trial
National Institutes of Health/National Institutes of Allergy and Infectious
Diseases, Margaret Easter. (301) 496-7196.
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PNEUMOCYSTIS CARINII PNEUMONIA PROTOCOLS
Aerosolized Pentamidine: (single previous episode of PCP)
Georgetown University, Dr. Philip Pierce. (202) 687-8672.
Aerosolized Pentamidine: (multiple episodes of PCP)
Georgetown University, Dr. Philip Pierce. (202) 687-8672.
Trimetrexate with leucovoran vs. Bactrim as treatment of Pneumocystis
pneumonia
Georgetown University, Dr. Mary Young. (202) 687-8672.
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MISCELLANEOUS
Brain Metabolism in HIV disease
National Institutes of Health/National Institute of Mental Health, Dr. Tom
Nordahl. (301) 496-4707.
Bronchoscopy in HIV infected persons
National Institutes of Health/National Institutes of Allergy and Infectious
Diseases, Barbara Baird. (301) 496-9565.
Event Related Brain Potentials in HIV disease
National Institutes of Health/National Institute of Mental Health, Dr.
Christine Ollo. (301) 496-6565.
Gadolinium enhanced MRI looking for CNS disease
National Institutes of Health/National Institutes of Allergy and Infectious
Diseases. (301) 496-7196.
HIV Heart Disease Study
George Washington University. (202) 994-2417.
Measurement of eye movement in HIV disease
National Institutes of Health/National Institute of Mental Health, Dr.
Robert Litman. (301) 496-6295.
Neuropsychiatric manifestations of HIV infection
National Institutes of Health/National Institute of Mental Health, Dr.
Christine Ollo. (301) 496-6565.
Salivary function in HIV infected individuals
National Institutes of Health/National Institutes of Allergy and Infectious
Diseases, Dr. Yeh. (301) 496-1478.
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Copyright (C) 1988,1989 by Washington HIV News, all rights reserved.
Permission is granted for non-commercial use only.