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)

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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 mi...

Gender

ALL

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.

Trial Officials