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)
Completed · Phase 2
Conditions studied: HIV Infections
In brief
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 patients with advanced disease. 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 with two nucleoside drugs or convergent combination therapy with two nucleosides and a non-nucleoside RT inhibitor may minimize the evolution of these resistant HIV strains. Since toxicity is a major problem in patients with advanced disease who are receiving combination nucleoside therapy, alternating the two drugs may provide a way of retaining several benefits of combination therapy while minimizing the increased toxicity.
Key facts
- Study ID
- NCT00000781
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 1292
- Expected to finish
- 1996-09-01
- Last updated by the study team
- 2021-11-04
Who can join
Age: 13 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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:
You may not qualify if…
- 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.
Where it is running
- Children's Hosp of Los Angeles — Los Angeles, California, United States
- Univ of Southern California / LA County USC Med Ctr — Los Angeles, California, United States
- Huntington Memorial Hosp / Children's Hosp of Los Angeles — Pasadena, California, United States
- Univ of California / San Diego Treatment Ctr — San Diego, California, United States
- San Francisco AIDS Clinic / San Francisco Gen Hosp — San Francisco, California, United States
- San Francisco Gen Hosp — San Francisco, California, United States
- Stanford at Kaiser / Kaiser Permanente Med Ctr — San Francisco, California, United States
- Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium — San Jose, California, United States
- San Mateo AIDS Program / Stanford Univ — Stanford, California, United States
- Stanford Univ Med Ctr — Stanford, California, United States
- Olive View Med Ctr — Sylmar, California, United States
- Harbor UCLA Med Ctr — Torrance, California, United States
- Denver Dept of Health and Hosps — Denver, Colorado, United States
- Mountain States Reg Hemo Ctr / Univ of Colorado — Denver, Colorado, United States
- Rose Med Ctr — Denver, Colorado, United States
- Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
- Yale Univ / New Haven — New Haven, Connecticut, United States
- HIV Ctr - District of Columbia Gen Hosp — Washington D.C., District of Columbia, United States
- Whitman - Walker Clinic / Georgetown Univ Med Ctr — Washington D.C., District of Columbia, United States
- Georgetown Univ Med Ctr — Washington D.C., District of Columbia, United States
- George Washington Univ / Hershey Med Ctr — Washington D.C., District of Columbia, United States
- Howard Univ — Washington D.C., District of Columbia, United States
- Univ of Miami School of Medicine — Miami, Florida, United States
- Univ of South Florida — Tampa, Florida, United States
- Univ of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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