GW873140 In Combination With Combivir In HIV Infected Subjects

• Status: Terminated
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a 96-week study designed to evaluate the safety and efficacy of GW873140 in combination with Combivir in HIV infected, untreated subjects.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline; ViiV Healthcare
• Treatments: Aplaviroc; Lamivudine, zidovudine drug combination

Criteria

Inclusion criteria:

• HIV infected subjects.

• Females must be of either non-childbearing age, or have a negative pregnancy test.

• All subjects participating in this study should be counseled on the practice of safe sex using a proven double barrier method of contraception throughout the study.

• Screening lab result of plasma HIV-1 RNA greater than or equal to 10,000 copies/mL and CD4 cell count greater than or equal to 100 cells/mm3.

• Have CC Chemokine Receptor5-tropic (R5-tropic) virus based on viral tropism test at screening visit.

• Have no drug resistance mutations in HIV-1 Reverse Transcriptase based on resistance test at screening visit.

• Be treatment-naive, defined as less than or equal to 2 weeks of treatment with a protease inhibitor (PI) or a nucleoside reverse transcriptase inhibitor/nucleotide reverse transcriptase inhibitor (NRTI/ NtRTI), or less than or equal to 7 days of therapy with a non-nucleoside reverse transcriptase inhibitor (NNRTI).

• Prior treatment with any entry inhibitor, attachment inhibitor, or fusion inhibitor (experimental or approved) is not allowed.

• Be able to understand and follow with protocol requirements, instructions and protocol-stated restrictions.

• Signed and dated written informed consent prior to study entry.

Exclusion criteria:

• Detection of any CXC Receptor4-tropic (X4-tropic) virus, based on viral tropism test at screening.

• Any drug resistance mutations in HIV-1 Reverse Transcriptase based on resistance test at screening visit.

• Active Class C AIDS-defining illness.

• Laboratory abnormalities at screen.

• Significant blood loss prior to study start.

• Pregnant or breastfeeding women.

• Additional qualifying criteria to be determined by the physician.