Viral dynamics of HIV: implications for drug development and therapeutic strategies.
D V Havlir, D D Richman
https://pubmed.ncbi.nlm.nih.gov/8624066Completed
Phase 2
Age: 12Years +
All Genders
ID00000625
A Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-02
2100
Participants Needed
58
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
To determine the efficacy and safety of zidovudine ( AZT ) versus didanosine ( ddI ), AZT plus ddI, and AZT plus zalcitabine ( ddC ) in preventing disease progression in HIV-infected patients with CD4 counts of 200-500 cells/mm3.
CONDITIONS
Official Title
A Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3
Who Can Participate
Age: 12Years +
All Genders
Eligibility Criteria
You may qualify if you...
Inclusion Criteria
Concurrent Medication:
Allowed:
- PCP prophylaxis, M. tuberculosis prophylaxis, short courses of acyclovir, chronic suppressive acyclovir, pneumovax or Hib vaccine, antibiotics, rEPO and G-CSF for grade 3 or worse anemia and neutropenia, systemic corticosteroids for < 21 days, regularly prescribed medications, and vitamins or herbal therapies.
Patients must have:
- HIV infection without AIDS with CD4 200-500 cells/mm3.
PER AMENDMENT 4/5/95:
- Patients must have remained on ACTG 175 study treatment through 4/30/95 and meet toxicity management criteria for continuing treatment. Subjects taking ACTG 175 crossover treatment are eligible.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions are excluded:
- Current AIDS-related condition other than minimal KS, grade 2 or worse peripheral neuropathy, and malignancy requiring systemic therapy.
Concurrent Medication:
Excluded:
- Other anti-HIV drugs, biologic response modifiers other than rEPO and G-CSF, systemic cytotoxic chemotherapy, chronic systemic corticosteroids, or any drug that affects AZT glucuronidation or clearance.
Concurrent Treatment:
Excluded:
- Radiotherapy other than limited local therapy to skin.
Patients with the following prior conditions are excluded:
- AIDS-related condition other than minimal KS; intolerance to AZT, ddI, or ddC at study doses; and acute or chronic pancreatitis.
Prior Medication:
Excluded:
- Acute therapy for an infection or other medical illness within the past 14 days.
Current alcohol abuse.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 58 locations
1
Alabama Therapeutics CRS
Birmingham, Alabama, United States, 35294
Status Unknown
2
USC CRS
Los Angeles, California, United States, 90033
Status Unknown
3
UCLA CARE Center CRS
Los Angeles, California, United States, 90095
Status Unknown
4
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, United States, 94609
Status Unknown
5
Stanford CRS
Palo Alto, California, United States, 94305
Status Unknown
6
UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California, United States, 92093
Status Unknown
7
Ucsd, Avrc Crs
San Diego, California, United States
Status Unknown
8
Ucsf Aids Crs
San Francisco, California, United States
Status Unknown
9
Santa Clara Valley Med. Ctr.
San Jose, California, United States, 95128
Status Unknown
10
San Mateo County AIDS Program
San Mateo, California, United States, 94305
Status Unknown
11
Harbor-UCLA Med. Ctr. CRS
Torrance, California, United States, 90502
Status Unknown
12
University of Colorado Hospital CRS
Aurora, Colorado, United States, 80262
Status Unknown
13
Howard University Hosp., Div. of Infectious Diseases, ACTU
Washington D.C., District of Columbia, United States, 20059
Status Unknown
14
Univ. of Miami AIDS CRS
Miami, Florida, United States, 33136
Status Unknown
15
Emory Univ. Hemophilia Program Office
Atlanta, Georgia, United States, 30365
Status Unknown
16
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States, 96816
Status Unknown
17
Northwestern University CRS
Chicago, Illinois, United States, 60611
Status Unknown
18
Cook County Hosp. CORE Ctr.
Chicago, Illinois, United States, 60612
Status Unknown
19
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, United States, 60612
Status Unknown
20
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States, 46202
Status Unknown
21
Methodist Hosp. of Indiana
Indianapolis, Indiana, United States, 46202
Status Unknown
22
Univ. of Iowa Healthcare, Div. of Infectious Diseases
Iowa City, Iowa, United States, 52242
Status Unknown
23
Tulane Hemophilia Treatment Ctr.
New Orleans, Louisiana, United States, 70112
Status Unknown
24
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
New Orleans, Louisiana, United States, 70112
Status Unknown
25
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, United States, 70112
Status Unknown
26
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States, 21287
Status Unknown
27
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, United States, 02114
Status Unknown
28
Brigham and Women's Hosp., Div. of Infectious Disease
Boston, Massachusetts, United States, 02115
Status Unknown
29
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States, 02115
Status Unknown
30
Bmc Actg Crs
Boston, Massachusetts, United States, 02118
Status Unknown
31
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, United States, 02215
Status Unknown
32
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, United States, 02215
Status Unknown
33
Hennepin County Med. Ctr., Div. of Infectious Diseases
Minneapolis, Minnesota, United States, 55455
Status Unknown
34
University of Minnesota, ACTU
Minneapolis, Minnesota, United States
Status Unknown
35
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, United States, 63112
Status Unknown
36
Washington U CRS
St Louis, Missouri, United States
Status Unknown
37
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
Omaha, Nebraska, United States
Status Unknown
38
NJ Med. School CRS
Newark, New Jersey, United States
Status Unknown
39
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, United States, 14215
Status Unknown
40
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, United States, 10003
Status Unknown
41
NY Univ. HIV/AIDS CRS
New York, New York, United States, 10016
Status Unknown
42
Cornell University A2201
New York, New York, United States, 10021
Status Unknown
43
Memorial Sloan-Kettering Cancer Ctr.
New York, New York, United States, 10021
Status Unknown
44
NYU Med. Ctr., Dept. of Medicine
New York, New York, United States
Status Unknown
45
Univ. of Rochester ACTG CRS
Rochester, New York, United States, 14642
Status Unknown
46
Unc Aids Crs
Chapel Hill, North Carolina, United States, 27599
Status Unknown
47
Carolinas HealthCare System, Carolinas Med. Ctr.
Charlotte, North Carolina, United States, 28203
Status Unknown
48
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina, United States, 27710
Status Unknown
49
Regional Center for Infectious Disease, Wendover Medical Center CRS
Greensboro, North Carolina, United States, 27401
Status Unknown
50
Wake County Health and Human Services CRS
Raleigh, North Carolina, United States, 27610
Status Unknown
51
Univ. of Cincinnati CRS
Cincinnati, Ohio, United States, 45267
Status Unknown
52
Case CRS
Cleveland, Ohio, United States, 44106
Status Unknown
53
MetroHealth CRS
Cleveland, Ohio, United States
Status Unknown
54
The Ohio State Univ. AIDS CRS
Columbus, Ohio, United States, 43210
Status Unknown
55
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, United States, 19104
Status Unknown
56
University of Washington AIDS CRS
Seattle, Washington, United States, 98122
Status Unknown
57
Puerto Rico-AIDS CRS
San Juan, Puerto Rico
Status Unknown
58
Mbeya Med. Research Program, Mbeya Referral Hosp. CRS
Mbeya, Tanzania
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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Published Research Related To This Trial
A trial comparing nucleoside monotherapy with combination therapy in HIV-infected adults with CD4 cell counts from 200 to 500 per cubic millimeter. AIDS Clinical Trials Group Study 175 Study Team.
S M Hammer, D A Katzenstein, M D Hughes...
https://pubmed.ncbi.nlm.nih.gov/8813038Neuromuscular function in HIV infection: analysis of a placebo-controlled combination antiretroviral trial. AIDS Clinical Group 175/801 Study Team.
D M Simpson, D A Katzenstein, M D Hughes...
https://pubmed.ncbi.nlm.nih.gov/9875580Zidovudine, didanosine, and zalcitabine in the treatment of HIV infection: meta-analyses of the randomised evidence. HIV Trialists' Collaborative Group.
https://pubmed.ncbi.nlm.nih.gov/10376616Virologic and CD4 cell response to zidovudine or zidovudine and lamivudine following didanosine treatment of human immunodeficiency virus infection.
D A Katzenstein, M D Hughes, M Albrecht...
https://pubmed.ncbi.nlm.nih.gov/11177402Development and validation of a self-completed HIV symptom index.
A C Justice, W Holmes, A L Gifford...
https://pubmed.ncbi.nlm.nih.gov/11750213The relation of virologic and immunologic markers to clinical outcomes after nucleoside therapy in HIV-infected adults with 200 to 500 CD4 cells per cubic millimeter. AIDS Clinical Trials Group Study 175 Virology Study Team.
D A Katzenstein, S M Hammer, M D Hughes...
https://pubmed.ncbi.nlm.nih.gov/8813039Changes in virologic markers as predictors of CD4 cell decline and progression of disease in human immunodeficiency virus type 1-infected adults treated with nucleosides. AIDS Clinical Trials Group Protocol 175 Team.
S A Fiscus, M D Hughes, J L Lathey...
https://pubmed.ncbi.nlm.nih.gov/9498441Differences between women and men in adverse events and CD4+ responses to nucleoside analogue therapy for HIV infection. The Aids Clinical Trials Group 175 Team.
J S Currier, C Spino, J Grimes...
https://pubmed.ncbi.nlm.nih.gov/11015147Characterizing patterns of drug-taking behavior with a multiple drug regimen in an AIDS clinical trial.
H Kastrissios, J R Suárez, D Katzenstein...
https://pubmed.ncbi.nlm.nih.gov/9863872