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GW873140 In Combination With Combivir In HIV Infected Subjects | Clinical Trials | Clareo Health

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GW873140 In Combination With Combivir In HIV Infected Subjects

A PhaseIIb, 96 Week, Randomised, Partially Double-blinded, Multicentre, Parallel Group, Repeat Dose Study to Evaluate the Safety, Tolerability, PK 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

NCT00104429•ViiV Healthcare

View on ClinicalTrials.gov

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.

Detailed Description

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (51)

GSK Investigational Site

Bakersfield, California, United States

GSK Investigational Site

Beverly Hills, California, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

San Francisco, California, United States

GSK Investigational Site

Stanford, California, United States

GSK Investigational Site

Tarzana, California, United States

GSK Investigational Site

Denver, Colorado, United States

GSK Investigational Site

Washington D.C., District of Columbia, United States

GSK Investigational Site

Miami, Florida, United States

Key Dates

Start Date

January 1, 2005

Primary Completion Date

January 1, 2006

Completion Date

January 1, 2006

Last Updated

May 30, 2017

Enrollment

125

Estimated participants

Conditions

Infection, Human Immunodeficiency Virus IHIV Infection

Interventions

GW873140

DRUG

Combivir

DRUG

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RECRUITING

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HIVHIV Infections

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 30, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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GW873140 In Combination With Combivir In HIV Infected Subjects

Inclusion Criteria

Exclusion Criteria

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