Overview

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.