New Tablet Containing Two FDA Approved Anti-HIV Drugs For Antiretroviral Therapy Experienced HIV-1 Infected Subjects

• Status: Completed
• Trial end date: 2004-05-25
• Target enrollment: 0
• Participant gender: All

Summary

A 48-week study to investigate the safety and effectiveness of a new compact formulation of two already FDA-approved anti-HIV drugs in subjects who have already been receiving treatment for their HIV infection.

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

Details

• Lead Sponsor: GlaxoSmithKline; ViiV Healthcare
• Treatments: Abacavir; Dideoxynucleosides; Lamivudine; Tenofovir

Criteria

Inclusion Criteria:

• Antiretroviral therapy (ART) experienced and currently receiving a stable regimen containing 3 nucleoside reverse transcriptase inhibitors (NRTIs), or 2 NRTIs plus a protease inhibitor (PI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) for at least 3 months (there should be no significant ART modifications for at least 3 months and no ART change anticipated between Screening and initiation of the study therapy).

• Patients must be naive to tenofovir.

• HIV-1 RNA level > 1000 copies/ml on at least one occasion within 21 days of study entry.

• A CD4 cell count > 50 cells/mm3.

• Specified viral genotypes.

Exclusion Criteria:

• Pregnant or breast-feeding women.

• Has an active diagnosis of AIDS.

• Additional qualifying criteria to be determined by the physician.