A Phase II, 48 Week, Open-Label Study Designed to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of a Simplified Dosing Regimen of Preveon (Adefovir Dipivoxil; bis-POM PMEA), Videx (Didanosine; ddI), Sustiva (Efavirenz; DMP-266), and Epivir (Lamivudine; 3TC) Administered Once Daily for the Treatment of HIV-1 Infection
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- HIV Infections
- Sponsor
- Gilead Sciences
- Enrollment
- 25
- Locations
- 5
- Status
- Completed
- Last Updated
- 20 years ago
Overview
Brief Summary
The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
Detailed Description
Patients receive a treatment regimen of adefovir dipivoxil, didanosine, efavirenz, and lamivudine for 48 weeks. During the study, patients are evaluated for changes from baseline in plasma HIV-1 RNA and lymphocyte subsets and for the development of adverse experiences and laboratory toxicities. At Weeks 8, 12, 24, and 48, patients are assessed for adherence to study treatment with a questionnaire. Patients who experience virologic failure are discontinued from the study. Patients who experience treatment intolerance may have their antiretroviral treatment regimens changed. After Week 48, patients with documented virologic response are eligible to continue receiving study treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified