Status:
COMPLETED
A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Bristol-Myers Squibb
Glaxo Wellcome
Conditions:
HIV Infections
Eligibility:
All Genders
13+ years
Phase:
PHASE2
Brief Summary
To determine the relative clinical efficacy of zidovudine ( AZT ) plus didanosine (ddI), AZT plus zalcitabine ( ddC ), AZT alternating monthly with ddI, and AZT/ddI plus nevirapine in HIV-infected pat...
Detailed Description
The rapid emergence of resistant HIV strains has been observed in patients receiving monotherapy with a nucleoside analog or non-nucleoside reverse transcriptase inhibitor. Use of combination therapy ...
Eligibility Criteria
Inclusion Criteria
Concurrent Medication:
Required:
- PCP prophylaxis.
Allowed:
- Erythropoietin maintenance.
- G-CSF and GM-CSF.
- Prophylaxis for Mycobacterium avium intracellulare.
- Antifungal prophylaxis or treatment with specific drugs.
- Maintenance therapy for opportunistic infection.
- Over-the-counter medications or alternative therapies such as vitamins and herbs.
- Antibiotics as clinically indicated.
- Steroids for < 21 days for acute problems.
- Antipyretics, analgesics, allergy medication, antidepressants, sleep medications, oral contraceptives, or other appropriate medications.
Concurrent Treatment:
Allowed:
- Radiation therapy for cutaneous Kaposi's sarcoma.
- Acupuncture.
Patients must have:
- Documented HIV infection.
- CD4 count <= 50 cells/mm3.
- Either no prior nucleoside therapy OR a history of prior nucleoside therapy in the absence of high-grade intolerance.
- Life expectancy of at least 6 months.
- Consent of parent or guardian if < 18 years of age.
- Normal chest x-ray at baseline or within 6 months prior to study entry in the absence of new pulmonary or cardiac symptoms (per 12/28/94 amendment).
NOTE:
- Patients who withdrew from protocol ACTG 193 therapy prior to activation of ACTG 193A are not eligible.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Abnormal baseline chest x-ray.
- New pulmonary or cardiac symptoms.
- Psychological or emotional problems sufficient to prevent compliance with study medication.
Concurrent Medication:
Excluded:
- Systemic chemotherapy for malignancy.
- Acute or induction therapy for opportunistic infection.
- Antiretroviral drugs other than study drugs.
- Biological response modifiers.
- Erythromycin, phenytoin, phenobarbital, warfarin, or coumadin.
Patients with the following prior conditions are excluded:
- History of recurrent grade 3 or greater toxicity to AZT, ddI, or ddC on two or more occasions.
- Evidence of active pulmonary disease within 6 months prior to study entry.
- History of grade 3 or worse peripheral neuropathy.
- History of acute or chronic pancreatitis.
Prior Medication:
Excluded:
- Prior nevirapine.
Excluded within 7 days prior to study entry:
- Acute therapy for opportunistic infection (maintenance therapy is permitted).
- Acute systemic therapy for a nonopportunistic infection or other medical condition.
- Antiretroviral drugs other than AZT, ddI, or ddC.
- Biological response modifiers.
- d4T therapy.
- Nucleosides other than those used in the study.
- Antibiotics containing clavulanate potassium.
Prior Treatment:
Excluded:
- More than 4 units of blood in a 30-day period.
Active alcohol or drug abuse.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
September 1 1996
Estimated Enrollment :
1292 Patients enrolled
Trial Details
Trial ID
NCT00000781
End Date
September 1 1996
Last Update
November 4 2021
Active Locations (96)
Enter a location and click search to find clinical trials sorted by distance.
1
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Children's Hosp of Los Angeles
Los Angeles, California, United States, 90027
3
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
4
Huntington Memorial Hosp / Children's Hosp of Los Angeles
Pasadena, California, United States, 91105