The Effectiveness of Three Drug Combinations in HIV-Infected Patients Who Have Taken Zidovudine for More Than 12 Weeks
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Didanosine, Drug Therapy, Combination, AIDS-Related Complex, Zidovudine, Stavudine
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Required for patients whose CD4 count falls below 200 cells/mm3: PCP prophylaxis with TMP/SMX, aerosolized pentamidine, or dapsone. Allowed: Atovaquone, IV pentamidine, trimethoprim-dapsone, clindamycin-primaquine, trimetrexate, or TMP/SMX for acute PCP. Topical antifungals, clotrimazole, ketoconazole, fluconazole, and amphotericin B for mucosal and esophageal candidiasis. Itraconazole. Amphotericin B. Rifabutin. Isoniazid. Pyrazinamide. Clofazimine. Clarithromycin. Azithromycin. Ethambutol. Amikacin. Ciprofloxacin. Ofloxacin. Pyrimethamine. Sulfadiazine. Clindamycin. Ganciclovir. G-CSF. Acyclovir (up to 1000 mg/day). Erythropoietin. Antibiotics for bacterial infections. Antipyretics. Analgesics. Antiemetics. Rifampin. Concurrent Treatment: Allowed: Local radiation therapy. Patients must have: HIV infection. CD4 count 300-600 cells/mm3. More than 12 weeks (was 24 weeks, AMENDED 3/31/96) of total prior AZT ( > 500 mg/day without serious adverse event). Subjects must be actively taking ZDV for at least 4 continuous weeks up to the time of study entry. No prior or current history of AIDS. No active opportunistic infection. Life expectancy of at least 2 years. Consent of patient and parent or guardian if less than 18 years of age. NOTE: Protocol is approved for prisoner enrollment. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Malignancy requiring systemic cytotoxic chemotherapy. Serious underlying medical condition other than HIV that would reduce life expectancy to < 2 years. Concurrent Medication: Excluded: Antiretrovirals other than study drugs. Foscarnet. Patients with the following prior conditions are excluded: Unexplained temperature >= 38.5 C for 7 days or chronic diarrhea (>= three stools daily) for 15 days, if occurring within 30 days prior to study entry. History of acute or chronic pancreatitis. History of grade 2 or higher peripheral neuropathy. History of grade 3 or worse intolerance to 500-600 mg/day AZT. Prior Medication: Excluded: (within 30 days prior to study entry) Prior ddI, ddC, 3TC or d4T (more than 2 weeks total). Non-nucleoside reverse transcriptase inhibitor or protease inhibitor. Biologic response modifiers such as interferon and IL-2. Other experimental therapy.
Sites / Locations
- UCLA CARE Center CRS
- Stanford CRS
- Ucsd, Avrc Crs
- Ucsf Aids Crs
- Harbor-UCLA Med. Ctr. CRS
- University of Colorado Hospital CRS
- Children's National Med. Ctr., ACTU
- Univ. of Florida Jacksonville NICHD CRS
- Univ. of Miami AIDS CRS
- Univ. of Hawaii at Manoa, Leahi Hosp.
- Northwestern University CRS
- Cook County Hosp. CORE Ctr.
- Rush Univ. Med. Ctr. ACTG CRS
- Weiss Memorial Hosp.
- Indiana Univ. School of Medicine, Infectious Disease Research Clinic
- Indiana Univ. School of Medicine, Wishard Memorial
- Methodist Hosp. of Indiana
- Tulane Hemophilia Treatment Ctr.
- Massachusetts General Hospital ACTG CRS
- Bmc Actg Crs
- Beth Israel Deaconess Med. Ctr., ACTG CRS
- Hennepin County Med. Ctr., Div. of Infectious Diseases
- University of Minnesota, ACTU
- St. Louis ConnectCare, Infectious Diseases Clinic
- Washington U CRS
- SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
- SUNY - Buffalo, Erie County Medical Ctr.
- Univ. of Rochester ACTG CRS
- Univ. of Cincinnati CRS
- The Ohio State Univ. AIDS CRS
- University of Washington AIDS CRS
- San Juan City Hosp. PR NICHD CRS
- Puerto Rico-AIDS CRS