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

Completed · Phase 3

Conditions studied: Infection, Human Immunodeficiency Virus I, HIV Infection

In brief

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.

Key facts

Study ID

NCT00044577

Run by

ViiV Healthcare

People needed

166

Starts

2002-07-16

Expected to finish

2004-05-25

Last updated by the study team

2020-03-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Pregnant or breast-feeding women.
• Has an active diagnosis of AIDS.
• Additional qualifying criteria to be determined by the physician.

Where it is running

• GSK Investigational Site — Oakland, California, United States
• GSK Investigational Site — Fort Lauderdale, Florida, United States
• GSK Investigational Site — Fort Lauderdale, Florida, United States
• GSK Investigational Site — Fort Lauderdale, Florida, United States
• GSK Investigational Site — Fort Myers, Florida, United States
• GSK Investigational Site — Jacksonville, Florida, United States
• GSK Investigational Site — Miami Beach, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Plantation, Florida, United States
• GSK Investigational Site — Tampa, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Augusta, Georgia, United States
• GSK Investigational Site — Indianapolis, Indiana, United States
• GSK Investigational Site — New Orleans, Louisiana, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — Stony Brook, New York, United States
• GSK Investigational Site — The Bronx, New York, United States
• GSK Investigational Site — Charlotte, North Carolina, United States
• GSK Investigational Site — Akron, Ohio, United States
• GSK Investigational Site — Philadelphia, Pennsylvania, United States
• GSK Investigational Site — Philadelphia, Pennsylvania, United States
• GSK Investigational Site — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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