GW873140 In Combination With Combivir In HIV Infected Subjects

Condition(s) targeted: HIV Infections

Intervention: GW873140 (Drug); Combivir (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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.

Official title: A Phase IIb, 96 Week, Randomized, Partially Double-Blinded, Multicenter, Parallel Group, Repeat Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Effect of GW873140 in Combination With Combivir (Lamivudine and Zidovudine) Upon Selected Immunological and Virological Markers of HIV-1 Infection in Antiretroviral Therapy Naive Adults

Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Proportion of subjects with viral loads <400 copies/mL remaining on randomized treatment through Week 12

Secondary outcome: - Comparison of safety and tolerability of different dosage regimens of GW873140 plus Combivir to standard of care regimen. - Assessment of drug resistance over time. - Co-receptor tropism following virological failure.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

GSK Clinical Trials Call Center, Little Rock, Arkansas 72207, United States

GSK Clinical Trials Call Center, San Francisco, California 94114, United States

GSK Clinical Trials Call Center, Tarzana, California 91356, United States

GSK Clinical Trials Call Center, Los Angeles, California 90095, United States

GSK Clinical Trials Call Center, Beverly Hills, California 90210, United States

GSK Clinical Trials Call Center, Los Angeles, California 90022, United States

GSK Clinical Trials Call Center, Stanford, California 94305, United States

GSK Clinical Trials Call Center, Bakersfield, California 93301, United States

GSK Clinical Trials Call Center, Denver, Colorado 80262, United States

GSK Clinical Trials Call Center, Denver, Colorado 80205, United States

GSK Clinical Trials Call Center, Washington, District of Columbia 20009, United States

GSK Clinical Trials Call Center, Washington, District of Columbia 20009, United States

GSK Clinical Trials Call Center, Atlantis, Florida 33462, United States

GSK Clinical Trials Call Center, Orlando, Florida 32803, United States

GSK Clinical Trials Call Center, Tampa, Florida 33607, United States

GSK Clinical Trials Call Center, Vero Beach, Florida 32960, United States

GSK Clinical Trials Call Center, Miami, Florida 33136, United States

GSK Clinical Trials Call Center, Ft. Lauderdale, Florida 33306, United States

GSK Clinical Trials Call Center, Chicago, Illinois 60612, United States

GSK Clinical Trials Call Center, Cambridge, Massachusetts 02139, United States

GSK Clinical Trials Call Center, Minneapolis, Minnesota 55404, United States

GSK Clinical Trials Call Center, Las Vegas, Nevada 89102, United States

GSK Clinical Trials Call Center, Newark, New Jersey 07102, United States

GSK Clinical Trials Call Center, Rochester, New York 14604, United States

GSK Clinical Trials Call Center, New York, New York 10018, United States

GSK Clinical Trials Call Center, Charlotte, North Carolina 28211, United States

GSK Clinical Trials Call Center, Toronto, Ontario M4N 3M5, Canada

GSK Clinical Trials Call Center, Ottawa, Ontario K1N 6N5, Canada

GSK Clinical Trials Call Center, Philadelphia, Pennsylvania 19107, United States

GSK Clinical Trials Call Center, Montreal, Quebec H2L 5B1, Canada

GSK Clinical Trials Call Center, Montreal, Quebec H2L 4P9, Canada

GSK Clinical Trials Call Center, Providence, Rhode Island 02817, United States

GSK Clinical Trials Call Center, Dallas, Texas 75246, United States

GSK Clinical Trials Call Center, Dallas, Texas 75208, United States

GSK Clinical Trials Call Center, Dallas, Texas 75215, United States

GSK Clinical Trials Call Center, Dallas, Texas 75246, United States

GSK Clinical Trials Call Center, Vancouver, Washington 98664, United States

Starting date: January 2005
Last updated: January 23, 2006