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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)

Phase 2
Completed
Conditions
HIV Infections
Registration Number
NCT00000781
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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 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.

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 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.

Patients are randomized to receive either AZT/ddC, AZT/ddI, AZT alternating monthly with ddI, or AZT/ddI/nevirapine. Patients are evaluated at week 0 and every 4 weeks thereafter for 2 years. Pharmacologic, virologic, and macroneurologic substudies will be conducted. Patients who are already enrolled on protocol ACTG 193 will be given the option of continuing on their originally assigned ACTG 193 therapy for an additional 6 months or undergoing re-randomization to one of the four treatment arms on ACTG 193A.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1292
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (96)

Univ of Alabama at Birmingham

🇺🇸

Birmingham, Alabama, United States

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

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Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States

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