Status:
COMPLETED
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
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Bristol-Myers Squibb
Glaxo Wellcome
Conditions:
HIV Infections
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
Patients are randomized to receive AZT alone, AZT and ddI, AZT and ddC, or ddI alone for at least 2 years. Patients who develop AIDS or whose CD4 count falls to 50 percent or less of baseline are cros...
Eligibility Criteria
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
November 1 1995
Estimated Enrollment :
2100 Patients enrolled
Trial Details
Trial ID
NCT00000625
End Date
November 1 1995
Last Update
November 2 2021
Active Locations (58)
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1
Alabama Therapeutics CRS
Birmingham, Alabama, United States, 35294
2
USC CRS
Los Angeles, California, United States, 90033
3
UCLA CARE Center CRS
Los Angeles, California, United States, 90095
4
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, United States, 94609