Study Of Investigational Regimen Combining FDA Approved HIV Drugs In HIV Subjects Experiencing Early Virologic Failure

ViiV Healthcare

Status and phase: Completed; Phase 4

Conditions: HIV Infection

Treatments: Drug: tenofovir; Drug: abacavir/lamivudine/zidovudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00038506

ESS 30005

Details and patient eligibility

About

This study is a 48-week study to evaluate the efficacy and safety of an investigational regimen combining FDA approved HIV drugs in antiretroviral-experienced subjects failing on their first highly active antiretroviral therapy regimen.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Currently on an initial HAART (highly active antiretroviral therapy) regimen of 3TC/ZDV or 3TC/d4T and a PI (protease inhibitor) -boosted or unboosted- or NNRTI (non-nucleoside reverse transcriptase inhibitor).
• Plasma HIV - 1 RNA was <400 copies/ml on at least 2 documented occasions prior to viral rebound.
• Have a plasma HIV - 1 RNA value >400 copies/ml and <10,000 copies/ml on 2 documented successive occasions (including screen) separated by at least 2 weeks.
• A CD4+ lymphocyte count less than or equal to 100.

Exclusion criteria

• Have not taken Abacavir (ZIAGEN or TRIZIVIR) or tenofovir (VIREAD) previously.
• Have not had an AIDS defining illness within 30 days of screen.
• Pregnant or breast-feeding.
• Specified viral genotypes upon screening.
• And other inclusion or exclusion criteria to be evaluated by the physician.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)