Comparing the Safety, Effectiveness, and Tolerability of Three Anti-HIV Drug Regimens for Treatment-Naive Patients

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

With new strategies and drugs available, many different regimens exist for the treatment of HIV. The purpose of this study is to compare three different anti-HIV drug regimens as first-time treatments for HIV infection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Efavirenz; Lamivudine; Lopinavir; Ritonavir; Stavudine; Tenofovir; Zidovudine

Criteria

Inclusion Criteria for Step 1:

• HIV infected

• HIV viral load of 2000 copies/ml or greater within 60 days prior to study entry

• Willing to use acceptable means of contraception

• d4T XR, TDF, or ZDV chosen as part of an initial regimen prior to randomization to a study arm

• Coenrolled in ACTG A5152s

Exclusion Criteria for Step 1:

• On ARV therapy for 7 days or more any time prior to study entry

• NNRTIs or 3TC at any time prior to study entry

• Current peripheral neuropathy of Grade 2 or higher

• Pregnancy or breastfeeding

• Immunomodulators, vaccines, or investigational therapies within 30 days of study entry. Patients taking a stable or tapering dose of prednisone at less than 10 mg are not excluded.

• Human growth hormone within 30 days prior to study entry

• Initiation of testosterone or anabolic steroids within 30 days prior to study entry

• Certain other medications within 30 days of study entry

• Hypersensitivity to components of the study drug formulations

• Drug or alcohol use or dependence that would interfere with adherence to study requirements

• Acute therapy for serious medical illnesses requiring systemic treatment and/or hospitalization within 14 days prior to study entry

• Recent infection with drug-resistant HIV