rock@uunet.UU.NET (02/25/90)
(continued)
RCD4-IGG CONJUGATE ("DESIGNER GENE")
DESCRIPTION: Study to compare the effects of giving recombinant CD4 (rCD4)
with attached Immunoglobulin G (the so-called "Designer Gene").
REQUIREMENTS: Participants must: be 18 years old or older; be p24 antigen
positive; have AIDS or ARC, with people with AIDS having one or no episodes
of a serious opportunistic infection, or having less than or equal to two
episodes of PCP; have a CD4 count less than 500 cells/mm^3; have not been on
AZT, chemotherapy, any other experimental therapy or immunomodulating drugs
within three weeks of entering the study; be willing to abstain from all
other experimental therapy for HIV infection during the course of the study;
and have laboratory tests within certain limits (granulocytes greater than
1000/mm^3; platelets greater than 75,000/mm^3; and normal liver and renal
(kidney) function). Women of childbearing potential must have a negative
pregnancy test, and be willing to practice a barrier method of birth control
for the duration of the study. Nursing mothers and people with active
opportunistic infections are excluded.
TERM: Three weeks inpatient at the NIH Clinic Center, followed by an
indefinite outpatient period.
ADMINISTRATION: The rCD4-IgG will be administered at escalating doses by
continuous IV infusion while inpatient, and given by intramuscular injection
twice a week while outpatient.
METHODOLOGY: rCD4 is a genetically-engineered version of the compound which
is on the surface of CD4 (T4) cells, however there is no actual CD4 cell
underneath it. Since HIV is a virus, and needs to attack, invade, and take
over another living cell in order to reproduce, it is hoped that if HIV
binds to rCD4 instead of actual CD4 cells, it will find itself attached to
something which cannot help it reproduce, and it will thus be rendered
ineffective. To assist in this, the rCD4 is chemically bound to
Immunoglobulin G, which is a "marker" produced by the body which tells the
rest of the immune system which foreign cells to kill. The combination
(conjugate) of rCD4 and IgG will hopefully provide the equivalent of
grabbing the virus to prevent it from doing damage, and hanging a "Kill Me"
sign on its back.
NOTES: This is no cost to the patient for the pre-study evaluations,
monitoring, or medications.
CONTROLS: None
ORGANIZATION: National Institutes of Health/National Cancer Institute
CONTACT: Debra Adamo, R.N., or Rose Thomas, R.N., Building 10, Room 12C101,
National Institutes of Health, Bethesda, MD 20892 (Medical Center METRO
stop). (301) 496-8959
***************************************************************************
CMV RETINITIS PROTOCOLS
----------------------------------------
FOSCARNET FOR SIGHT-THREATENING CMV RETINITIS (ACTG 093)
DESCRIPTION: Study of the effectiveness and side effects of foscarnet
(trisodium phosphonoformate) in the treatment of sight-threating CMV
retinitis.
REQUIREMENTS: Participants must have AIDS as defined by the CDC, or a
positive p24 antigen test, HIV culture, or ELISA and Western Blot.
Participants must also have sight-threatening CMV retinitis, that is,
visible CMV lesions within 3000 microns of the fovea or 1500 microns of the
optic disk. Participants must either be unable to take ganciclovir (DHPG),
either because of intolerance (defined as having the count of absolute
neutrophils drop below 750/mm^3, or having platelets drop below 25,000/mm^3
on two occasions while receiving ganciclovir), resistance (new lesions or
advancing lesions despite therapy with ganciclovir), or low blood counts
(absolute neutrophils below 750/mm^3, or platelets below 25,000/mm^3 without
ganciclovir therapy). Vision in the affected eye(s) has to be correctable
to 20/100 or better, or be reasonably expected to improve to that level.
Participants also must be: able to give informed consent; between 13 and 65
years of age (inclusive), and people between 13 and 18 must have written
consent of their guardian; require considerable assistance and frequent
medical care, or be more able (a Karnofsky performance of 50 or higher).
Laboratory tests must also be within certain limits (serum creatinine less
than or equal to 2.0 mg/dl). Women of child-bearing potential must have a
negative pregnancy test within 14 days of the start of the study, and be
willing to practice birth control for the duration of the study, and for at
least three months afterwards.
People with the following are excluded: physical disabilities;
opacification of the lens (such as caused by cataracts, etc.) which prevents
fundascopic examination; previous treatment with foscarnet for CMV
retinitis; concurrent treatment with immunomodulators, lymphocyte
replacement therapy, nephrotoxic agents, or biologic response modifiers;
previous hypersensitivity reaction to foscarnet; pre-existing severe
neurologic impairment (e.g. seizure disorder, marked or incapacitating
ataxia); nursing mothers. Participants may not take AZT for the first two
weeks. Prophylaxis for PNEUMOCYSTIS CARINII pneumonia is permitted.
Chemotherapy for Kaposi's sarcoma is permitted, as long as the participant
is hematologically stable for at least 30 days prior to entry in the study.
TERM: One week inpatient, up to 52 weeks outpatient.
ADMINISTRATION: Participants will receive foscarnet by intermittent
intravenous infusion. Weekly clinic visits are required during the
outpatient period. Participants will probably need to have a Hichman or
other indwelling catheter (a plastic tube imbedded in the chest which leads
directly to a major vein) implanted for the administration of the foscarnet.
METHODOLOGY: Foscarnet has demonstrated activity against CMV, which is the
virus which causes CMV retinitis. Foscarnet interferes with the replication
of CMV, thus slowing the progression of CMV retinitis. Foscarnet has also
shown activity against HIV (the virus which causes AIDS).
NOTES: Possible side effects of foscarnet therapy include kidney damage,
decrease in hemoglobin concentration or white cell count, nausea and/or
vomiting, inflammation at the vein site where it is infused, changes in
serum calcium and/or phosphorous, headache, convulsions, or heart rhythm
disturbances. Since the foscarnet is distributed in heavy glass bottles,
some participants may require assistance while self-administering the drug.
CONTROLS: None
ORGANIZATION: George Washington University, one of the AIDS Treatment
Evaluation Units (ATEUs) run by NIH.
CONTACT: Interested people should have their doctor call Dr. David Parenti,
George Washington University, (202) 994-4716, or call Maribeth Goldin at
(202) 994-2417 for more information.
***************************************************************************
PNEUMOCYSTIS CARINII PNEUMONIA (PCP) PROTOCOLS
----------------------------------------
AEROSOLIZED PENTAMIDINE VS. DAPSONE VS. TRIMETHOPRIM/SULFAMETHOXAZOLE
(BACTRIM) IN COMBINATION WITH AZT IN ARC PATIENTS (ACTG 081)
DESCRIPTION: Randomized study of the effectiveness and side effects of
aerosolized pentamidine vs. Dapsone vs. Trimethoprim/Sulfamethoxazole (T-
SMZ) used for prophylaxis (prevention) of PNEUMOCYSTIS CARINII pneumonia
(PCP) when combined with AZT therapy in people with ARC.
REQUIREMENTS: Participants must have: a positive ELISA antibody test, p24
antigen test, or HIV culture; NO history of documented or presumed
toxoplasmosis or pneumocystosis; less than 200 CD4 cells/mm^3 at any time
prior to the study; no active bacterial or mycobacterial infection; at least
13 years of age, and people between 13 and 18 must have written consent of
their guardian; at least 40 kg of weight. Laboratory tests must also be
within certain limits (hemoglobin greater than or equal to 9.4 g/dl;
absolute neutrophil count greater than or equal to 1000 cells/mm^3; platelet
count greater than 75,000 platelets/mm^3; creatinine greater than 50 ml/min;
transaminases less than 10 times the upper limit or normal; no evidence of
G-6-PD deficiency). Women of child-bearing potential must have a negative
pregnancy test within 14 days of the start of the study, and be willing to
practice birth control for the duration of the study.
People with the following are excluded: treatment-limiting hypersensitivity
to sulfonamides, trimethoprim, pentamidine, or AZT; history of intolerance
to AZT for more than 72 hours or causing dose reduction to less than 500
mg/day within four weeks prior to entry; received other forms of
pneumocystosis prophylaxis within four weeks of the study; receiving DHPG;
on active treatment for an infection or malignancy; KS or other malignancy
(except basal cell (skin cancer) carcinoma) which has been rapidly
progressing in the month prior to enrollment, and which may be expected to
require chemotherapy within 90 days of entry into the study; nursing
mothers; active alcohol or drug abuse; require therapy with an
investigational agent except those receiving maintenance therapy with
fluconazole or itraconazole for a systemic mycosis.
TERM: At least 18 months; average time will be two years.
ADMINISTRATION: Participants with less than six weeks experience with AZT
will be started on AZT for two weeks before other therapy begins. All
participants will receive either a 200 mg or 100 mg dose of AZT orally (by
mouth) five times a day. Participants will then be divided into three
groups: the first group will receive a daily dose of 160 mg of Trimethoprim
and 800 mg of Sulfamethoxazole; the second group will get 300 mg of
aerosolized pentamidine every four weeks using a nebulizer; and the third
group will receive a dose of 25 mg of Dapsone by mouth twice a day.
Participants will return for clinic visits weekly for two weeks, biweekly
for the next six weeks, and every four weeks for the remainder of the study.
Some dose modifications may be performed if the participant shows
significant toxicity.
METHODOLOGY: PNEUMOCYSTIS CARINII pneumonia is one of the most common
opportunistic infections affecting AIDS patients, appearing one or more
times in about 65 percent of them. Trimethoprim/Sulfamethoxazole (also
known as Bactrim) and Dapsone are both pills with proven effectiveness in
reducing the rate of PCP relapse. Pentamidine is a drug which is often
taken intravenously during acute treatment for PCP, and has demonstrated
effectiveness in reducing the relapse rate of PCP when "aerosolized" and
inhaled directly into the lungs. Pentamidine is aerosolized by a machine
called a "nebulizer," most commonly the Respirgard II, which acts like an
extremely precise humidifier with a mouthpiece. T-SMZ and Dapsone have the
added advantage that they are also effective against Toxoplasmosis, both in
the lungs and elsewhere, whereas aerosolized pentamidine appears to be ONLY
effective against PCP, and only in the lungs.
AZT is a "Chain Terminator," a "fake" version of the DNA base thymidine
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" AZT gets
added to the DNA strand instead of real thymidine. AZT 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.
NOTES: Possible side effects of Trimethoprim/Sulfamethoxazole include
nausea, vomiting, skin rashes which may be severe, and a decrease in white
blood cell counts. Possible side effects of aerosolized pentamidine include
irritation, sore throat, and possible lung spasms or coughing for people
with prior history of asthma or smoking. Possible side effects of Dapsone
include anemia, methemoglobinemia (a condition in which the hemoglobin has
been changed by a toxic substance), decreased white blood cells, hepatitis,
rash, nausea, and fatigue. Possible side effects of AZT include lowered
white blood cell count, anemia, headache, mild confusion, fatigue, anxiety,
nausea, skin rashes, dizziness, and muscle pain.
CONTROLS: None. All participants will receive AZT, and will receive either
aerosolized pentamidine, Dapsone or Trimethoprim/Sulfamethoxazole.
ORGANIZATIONS: George Washington University, one of the AIDS Treatment
Evaluation Units (ATEUs) run by NIH; and the Whitman-Walker Clinic.
CONTACTS: Maribeth Goldin, George Washington University AIDS Clinical
Trials Unit, 2300 I Street, N.W., Room 202, Washington, DC 20037, (202)
994-2417
Basil Vareldzis, Whitman-Walker Clinic, 1407 "S" Street, N.W., Washington,
DC 20009, (202) 797-3534
For hemophiliacs and people with other blood disorders, contact Stacy
Russell, George Washington University Hematology/Oncology Clinic, 2150
Pennsylvania Avenue, N.W., Washington, DC 20037, (202) 994-4200
----------------------------------------
AEROSOLIZED PENTAMIDINE VS. TRIMETHOPRIM/SULFAMETHOXAZOLE (BACTRIM) IN
COMBINATION WITH AZT IN AIDS PATIENTS (ACTG 021)
DESCRIPTION: Randomized study of the effectiveness and side effects of
aerosolized pentamidine vs. Trimethoprim/Sulfamethoxazole (T-SMZ) used for
prophylaxis (prevention) of PNEUMOCYSTIS CARINII pneumonia (PCP) when
combined with AZT therapy in people with AIDS.
REQUIREMENTS: Participants must have AIDS as defined by the CDC, and have
successfully recovered from an initial episode of PCP. The PCP must be
documented by bronchoscopy, lung washings, or a sputum test. The PCP must
have been treated by either 14 days continuous therapy with Sulfamethoxazole
(at least 75 mg/kg/day) combined with Trimethoprim (at least 15 mg/kg/day),
or parenteral (IV) pentamidine (at least 4 mg/kg/day); or at least 21 days
of anti-pneumocystis therapy, including aerosolized pentamidine, Dapsone
plus Trimethoprim, Sulfadiazine plus Pyrimethamine, or Trimetrexate plus
Leucovorin. Participants must enter the study within ten weeks of
completing therapy for PCP.
Participants also must be: at least 12 years of age, and people between 12
and 18 must have written consent of their guardian; able to tolerate oral
and aerosolized therapy; able to care for most everyday needs requiring only
occasional assistance (a Karnofsky performance of 60). Laboratory tests
must also be within certain limits (granulocyte count greater than 1000
cells/mm^3; platelet count greater than 75,000 platelets/mm^3; hemoglobin
greater than or equal to 9.0 g/dl with no transfusions within the previous
two weeks; serum creatinine less than 1.5 times the upper limit of normal;
transaminases less than five times the upper limit or normal; bilirubin less
than three times the upper limit of normal). Women of child-bearing
potential must have a negative pregnancy test within 14 days of the start of
the study, and be willing to practice birth control for the duration of the
study.
People with the following are excluded: treatment-limiting hypersensitivity
to sulfonamides, trimethoprim, pentamidine, or AZT; severe hypoglycemia
(serum glucose less than 50 mg/dl) as a result of aerosolized or parenteral
pentamidine therapy; nursing mothers; active alcohol or drug abuse; known
Kaposi's sarcoma visceral disease (internal KS, not skin lesions); history
of neoplasms (cancer cells) other than basal cell (skin cancer) or IN-SITU
carcinoma of the cervix; KNOWN glucose-6-phosphate dehydrogenase (G-6-PD)
deficiency (predominantly those of African ancestry). People are also
excluded who have received more than the following AFTER acute treatment of
their initial PCP episode: two weeks of T-SMZ or Dapsone; two doses of
Pyrimethamine/Sulfadoxine; or one treatment with aerosolized pentamidine.
TERM: At least six months; average time will be one year.
ADMINISTRATION: All participants will receive either 200 mg or 100 mg dose
of AZT orally (by mouth) every four hours while awake. Participants will
then be divided into two groups: the first group will receive a daily dose
of 160 mg of Trimethoprim and 800 mg of Sulfamethoxazole; the second group
will get 300 mg of aerosolized pentamidine every four weeks using a
nebulizer. Participants will return for clinic visits weekly for eight
weeks, and every two weeks for the remainder of the study. Some dose
modifications may be performed if the participant shows significant
toxicity.
METHODOLOGY: PNEUMOCYSTIS CARINII pneumonia is one of the most common
opportunistic infections affecting AIDS patients, appearing one or more
times in about 65 percent of them. Trimethoprim/Sulfamethoxazole (also
known as Bactrim) is a pill with proven effectiveness in reducing the rate
of PCP relapse. Pentamidine is a drug which is often taken intravenously
during acute treatment for PCP, and has demonstrated effectiveness in
reducing the relapse rate of PCP when "aerosolized" and inhaled directly
into the lungs. Pentamidine is aerosolized by a machine called a
"nebulizer," most commonly the Respirgard II, which acts like an extremely
precise humidifier with a mouthpiece. T-SMZ (Bactrim) has the added
advantage that it is also effectiveness against Toxoplasmosis, both in the
lungs and elsewhere, whereas aerosolized pentamidine appears to be ONLY
effective against PCP, and only in the lungs.
AZT is a "Chain Terminator," a "fake" version of the DNA base thymidine
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" AZT gets
added to the DNA strand instead of real thymidine. AZT 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.
NOTES: Possible side effects of Trimethoprim/Sulfamethoxazole include
nausea, vomiting, skin rashes which may be severe, and a decrease in white
blood cell counts. Possible side effects of aerosolized pentamidine include
irritation, sore throat, and possible lung spasms or coughing for people
with prior history of asthma or smoking. Possible side effects of AZT
include lowered white blood cell count, anemia, headache, mild confusion,
fatigue, anxiety, nausea, skin rashes, dizziness, and muscle pain.
CONTROLS: None. All participants will receive AZT, and will receive either
aerosolized pentamidine or Trimethoprim/Sulfamethoxazole.
ORGANIZATION: George Washington University, one of the AIDS Treatment
Evaluation Units (ATEUs) run by NIH.
CONTACT: Maribeth Goldin, George Washington University AIDS Clinical Trials
Unit, 2300 I Street, N.W., Room 202, Washington, DC 20037, (202) 994-2417
***************************************************************************
MISCELLANEOUS PROTOCOLS
----------------------------------------
COPING RESPONSE IN HIV INFECTION
DESCRIPTION: Study to learn more about the physical and psychosocial needs
of people with HIV infection who are currently or have in the past
experienced illness.
REQUIREMENTS: Participants must be HIV-infected, and have experienced or be
currently experiencing HIV-related symptoms such as: opportunistic
infections, nausea, diarrhea, loss of appetite, respiratory problems, or
others.
TERM: Three years
ADMINISTRATION: The study involves meeting every three to four months with
a staff member, in a private place of the participant's choosing, for
approximately one to two hours to answer a questionnaire. Participants will
also receive monthly phone calls.
METHODOLOGY: The study will gather information about patient care needs
during HIV infection, to assist in determining appropriate nursing
therapies. Information will be collected on the social support, self-
sufficiency, coping response, and physical and psychosocial adaptations made
by HIV-infected persons. This data will be analyzed and compared to data
about severity of illnesses, stressful life circumstances, personality
adjustments, mode of illness transmission, age, and socio-economic status.
Analysis of the use and effectiveness of health care services will also be
studied.
NOTES: No treatment is offered during this study.
CONTROLS: Not applicable
ORGANIZATION: National Institutes of Health funded study at the Catholic
University of America School of Nursing
CONTACT: Mary Elizabeth O'Brien, Ph.D., R.N., Director of Research, Room
122, Gowan Hall, Catholic University of America, Washington, DC 20064,
(202) 635-5400 [day] or (301) 864-4831 [evenings]
----------------------------------------
FOSCARNET VS. VIDARABINE TO TREAT ACYCLOVIR-RESISTANT HERPES SIMPLEX (ACTG
095)
DESCRIPTION: Randomized study of the effectiveness and side effects of
foscarnet (trisodium phosphonoformate) vs. vidarabine (adenosine
arabinoside) to treat Herpes Simplex infections which have been resistant to
acyclovir (which is the standard therapy).
REQUIREMENTS: Participants must have AIDS as defined by the CDC, or a
positive p24 antigen test, HIV culture, or ELISA and Western Blot.
Participants must also have mucocutaneous Herpes Simplex Virus (HSV)
infection, confirmed by viral culture, persisting for a minimum of two weeks
which is clinically resistant to therapy with acyclovir, in the opinion of
the patient's physician.
Participants also must be: able to give informed consent; between 13 and 65
years of age (inclusive), and people between 13 and 18 must have written
consent of their guardian; physically able to live outside an acute care
setting (a Karnofsky performance of 40 or higher). Laboratory tests must
also be within certain limits (serum creatinine less than or equal to 2.0
mg/dl; absolute neutrophil count greater than or equal to 500 cells/mm^3;
platelet count greater than or equal to 25,000 platelets/mm^3; bilirubin
less than or equal to 2.5 times the upper limit of normal; AST (SGOT) less
than or equal to five times the upper limit of normal; alkaline phosphatase
less than or equal to 2.5 times the upper limit of normal; serum calcium
(adjusted for albumin) greater than or equal to seven mg/dl and less than 12
mg/dl; serum phosphorus greater than or equal to one mg/dl and less than or
equal to eight mg/dl). Women of child-bearing potential must have a
negative pregnancy test within 14 days of the start of the study, and be
willing to practice birth control for the duration of the study, and for at
least three months afterwards.
People with the following are excluded: concurrent treatment with
ganciclovir (DHPG), although treatment may be suspended upon entry into the
study, and resumed after the study period; treatment with foscarnet within
30 days prior to study entry; treatment with immunomodulators, lymphocyte
replacement therapy, or biologic response modifiers within 14 days prior to
study entry; previous hypersensitivity reaction to foscarnet or vidarabine
(participants with documented intolerance to vidarabine may still be
eligible for foscarnet); pre-existing severe neurologic impairment (e.g.
seizure disorder, marked or incapacitating ataxia); nursing mothers.
Participants may not take any other drugs, including AZT, during the study
period.
TERM: 10 days for the first phase; a minimum of 10 and a maximum of 21 days
for the second phase. There is also a 12 week follow-up period.
ADMINISTRATION: During the first (inpatient) phase, participants will
receive acyclovir intravenously at a dose level of at least five mg/kg every
eight hours for 10 consecutive days. In order to progress to the second
phase, participants must show persistent shedding of HSV at the completion
of the 10 day course of treatment, confirmed by viral culture, with
documented IN VITRO (in the test tube) resistance of the virus to acyclovir.
If participants have completed a well-documented course of acyclovir
treatment for at least 10 days, either at home or in a hospital setting, the
first phase may be skipped as long as they meet the necessary requirements
to enter the second phase. Participants whose HSV lesions show a "healed"
or "good" response after acyclovir treatment are not eligible to enter the
second phase (this study is only for acyclovir-resistant HSV).
In the second phase, participants will randomly receive either foscarnet by
intermittent intravenous infusion every eight hours at a dose level of 40
mg/kg (modifiable as needed) for a period of one hour, or vidarabine by
intravenous infusion at a dose level of 15 mg/kg/day over a period of 12
hours. If the lesions heal completely, therapy will be stopped. If the
lesions show "good" or "partial" response, therapy will be continued for up
to 21 days, with a possible extension to 42 days if there appears to be a
clinical benefit to doing so. If the lesions show a "poor" response after
10 days, therapy will be stopped.
Participants will return for clinic visits after the first, second, fourth,
eighth, and twelfth weeks weeks of the follow-up period.
METHODOLOGY: Acyclovir has a proven ability to interfere with Herpes
Simplex Virus (HSV) reproduction, and has been the standard therapy for HSV
infection since the early 1970s. However, laboratory tests have shown that
two strains of HSV have developed, one which responds to acyclovir, and one
which does not. This study attempts to isolate and inhibit the acyclovir-
resistant strain of HSV by using either foscarnet or vidarabine, which both
have proven in the test tube to be effective against HSV. Acyclovir,
foscarnet, and vidarabine all use completely different mechanisms to attack
HSV, so preliminary results have shown that HSV which is resistant to
acyclovir can be treated effectively by either foscarnet or vidarabine. In
addition, foscarnet has shown activity against HIV, and vidarabine has shown
activity against CMV.
NOTES: Possible side effects of foscarnet therapy include kidney damage,
decrease in hemoglobin concentration or white cell count, nausea and/or
vomiting, inflammation at the vein site where it is infused, changes in
serum calcium and/or phosphorous, headache, convulsions, or heart rhythm
disturbances. Side effects of vidarabine include nausea, tremor,
convulsions, hallucinations, dizziness, headache, and difficulty with
balance. Temporary decreases in blood cell counts and platelet counts may
also occur, as may abnormal liver blood tests.
CONTROLS: None. Participants may receive acyclovir, and if they qualify
will receive either foscarnet or vidarabine.
ORGANIZATION: George Washington University, one of the AIDS Treatment
Evaluation Units (ATEUs) run by NIH.
CONTACT: Maribeth Goldin, George Washington University AIDS Clinical Trials
Unit, 2300 I Street, N.W., Room 202, Washington, DC 20037, (202) 994-2417
----------------------------------------
NEUROPSYCHOLOGICAL TESTING
DESCRIPTION: A series of psychological tests.
REQUIREMENTS: These tests are for either HIV-positive or HIV-negative
people. People who have not been tested for HIV, or have not been tested
recently, will be tested. Participants should not be on any
neuropsychiatric drugs or currently have a drug or alcohol related illness.
TERM: 16 weeks
ADMINISTRATION: The initial series of tests lasts four hours. The other
tests last one to two hours, and are taken every two weeks for the remainder
of the study period. Testing takes places at the National Institutes of
Mental Health in Bethesda, Maryland, and at sites in the District of
Columbia. Evening hours will be available both in the District and at NIH.
COMPENSATION: People completing the full 16-week series of tests are
eligible for compensation of $150.00 to $300.00, depending on amount of time
required.
METHODOLOGY: HIV has been shown to cross the blood-brain barrier, and cause
various neurological disturbances. These testing procedures to assess
memory cognitive processing speed, attention, and motor speed are being
evaluated for use in anti-HIV drug studies. The study will test the
stability of scores across time and will be a comparison to patients being
given experimental anti-HIV therapies.
NOTES: Reimbursement is available for travel to and from the NIMH. All the
testing done is non-invasive, i.e. participants will not get "stuck" with
needles or anything else. No treatment is performed during this study.
CONTROLS: Not applicable
ORGANIZATION: National Institutes of Health/National Institute of Mental
Health
CONTACT: Dr. Peter Bridge, Building 10, Room 4N224, National Institutes of
Health, Bethesda, MD 20892 (Medical Center METRO stop). (301) 496-7789
***************************************************************************
PREVIOUSLY COVERED PROTOCOLS
The following protocols were covered in-depth in the August, 1989 (Volume 1,
Number 3) issue of WASHINGTON HIV NEWS:
----------------------------------------
ANTI-RETROVIRAL PROTOCOLS
ALPHA INTERFERON AND INTERLEUKIN-2 in people with HIV infection. CONTACT:
Dianne Lee, Building 10, 11th floor clinic, National Institutes of Health,
Bethesda, MD 20892 (Medical Center METRO stop). (301) 496-7196
AS-101 AND AZT in people with HIV and CD4 less than 200/mm^3. CONTACT:
Debbie Ogata-Arakaki, Building 10, Room 10D48, National Institutes of
Health, Bethesda, MD 20892, (301) 496-9565
AZDU in people with HIV infection. CONTACT: Dianne Lee, Building 10, Room
11B09, National Institutes of Health, Bethesda, MD 20892 (Medical Center
METRO stop). (301) 496-7196
AZT AND ACYCLOVIR (ACTG 063) in patients with AIDS. CONTACT: Kathryn
Grabowy, George Washington University AIDS Clinical Trials Unit, 2300 I
Street, N.W., Room 202, Washington, DC 20037, (202) 994-2417. For
hemophiliacs and people with other blood disorders, contact Stacy Russell,
George Washington University Hematology/Oncology Clinic, 2150 Pennsylvania
Avenue, N.W., Washington, DC 20037, (202) 994-4200
AZT AND ALPHA INTERFERON in people with HIV infection. CONTACT: Frank
Cefali, Building 10, Room 11B09, National Institutes of Health, Bethesda, MD
20892 (Medical Center METRO stop). (301) 496-9565
AZT AND GM-CSF in patients with AIDS or symptomatic HIV infection. CONTACT:
Dr. James Pluda, Building 10, Room 13N248, National Institutes of Health,
Bethesda, MD 20892 (Medical Center METRO stop). (301) 496-8398
AZT AND INTERLEUKIN-2 in people with HIV infection. CONTACT: Dianne Lee,
Building 10, 11th floor clinic, National Institutes of Health, Bethesda, MD
20892 (Medical Center METRO stop). (301) 496-7196
AZT FOR VETERANS with ARC (AIDS Related Complex). CONTACT: Pat Kramer or
John Scott, Veterans Affairs Medical Center, 50 Irving Street, N.W.,
Washington, DC 20422, (202) 745-8694
BETASERON (BETA INTERFERON) AND REDUCED DOSE AZT in AIDS and advanced ARC
patients. CONTACT: Grace Gianturco, George Washington University AIDS
Clinical Trials Unit, 2300 I Street, N.W., Room 202, Washington, DC 20037,
(202) 994-2417
----------------------------------------
PNEUMOCYSTIS CARINII PNEUMONIA PROTOCOLS
DAPSONE OR DAPSONE/PYRIMETHAMINE for PCP prophylaxis. CONTACTS: Georgetown
University Hospital (Center for HIV Disease): Dr. James Lavelle, Georgetown
University Hospital, 3800 Reservoir Road, N.W., Washington, DC 20007,
(202) 687-8826. National Institutes of Health: Debbie Ogata-Arakaki,
Building 10, Room 10D48, National Institutes of Health, Bethesda, MD 20892,
(301) 496-9565
----------------------------------------
CMV RETINITIS PROTOCOLS
GANCICYCLOVIR (DHPG) FOR CMV RETINITIS (ACTG 071) which is not immediately
sight-threatening. CONTACT: Interested people should have their doctor
call Dr. David Parenti, George Washington University, (202) 994-4716, or
call Maribeth Goldin at (202) 994-2417 for more information.
----------------------------------------
TOXOPLASMOSIS PROTOCOLS
PYRIMETHAMINE AND DAPSONE FOR TOXOPLASMOSIS in persons with AIDS who are
resistant to or intolerant of conventional therapy. CONTACTS: Georgetown
University Hospital (Center for HIV Disease): Dr. James Lavelle, Georgetown
University Hospital, 3800 Reservoir Road, N.W., Washington, DC 20007,
(202) 687-8826; National Institutes of Health: Debbie Ogata-Arakaki,
Building 10, Room 10D48, National Institutes of Health, Bethesda, MD
20892, (301) 496-9565
----------------------------------------
MISCELLANEOUS PROTOCOLS
BRONCHOSCOPY STUDY. CONTACT: Debbie Ogata-Arakaki, Building 10, Room
10D48, National Institutes of Health, Bethesda, MD 20892, (301) 496-9565
HIV & HEART DISEASE STUDY. CONTACT: Sara Adams, Room 2440 North, George
Washington University Hospital, 901 23rd Street, N.W., Washington, DC
20037, (202) 994-3909
MEGACE causes increased appetite and weight gain. CONTACT: Pat Kramer or
John Scott, Veterans Affairs Medical Center, 50 Irving Street, N.W.,
Washington, DC 20422, (202) 745-8694; Maribeth Goldin, George Washington
University AIDS Clinical Trials Unit, 2300 I Street, N.W., Room 202,
Washington, DC 20037, (202) 994-2417
----------------------------------------
For the most up-to-date information on other protocols, call the NIAID AIDS
Trial Line at 1-(800) TRIALS-A [874-2572].
***************************************************************************
Copyright (C) 1988,1989,1990 by Washington HIV News, all rights reserved.
Permission is granted for non-commercial use only.