GW873140 In Combination With Combivir In HIV Infected Subjects

NCT00104429 | Terminated Phase 2

• 1 other identifier: 102881
• Study Type: interventional
• Target: 125
• Locations: 9 countries
• Sites: 51

Brief 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.

Conditions

Infection, Human Immunodeficiency Virus I; HIV Infection

Keywords

HIV infections; therapy naive

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• - 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.

Interventions

GW873140 DRUG

Combivir DRUG

Also known as: GW873140

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ViiV Healthcare: lead

Study Sites (51)

GSK Investigational Site

Bakersfield, California, 93301, United States

Location

GSK Investigational Site

Beverly Hills, California, 90210, United States

Location

GSK Investigational Site

Los Angeles, California, 90022, United States

Location

GSK Investigational Site

Los Angeles, California, 90095, United States

Location

GSK Investigational Site

San Francisco, California, 94114, United States

Location

GSK Investigational Site

Stanford, California, 94305, United States

Location

GSK Investigational Site

Tarzana, California, 30342, United States

Location

GSK Investigational Site

Denver, Colorado, 80205, United States

Location

GSK Investigational Site

Washington D.C., District of Columbia, 20009, United States

Location

GSK Investigational Site

Miami, Florida, 33136, United States

Location

GSK Investigational Site

Orlando, Florida, 32804, United States

Location

GSK Investigational Site

Tampa, Florida, 33607, United States

Location

GSK Investigational Site

Vero Beach, Florida, 32960, United States

Location

GSK Investigational Site

Conyers, Georgia, 30013, United States

Location

GSK Investigational Site

Chicago, Illinois, 60612, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02114, United States

Location

GSK Investigational Site

Minneapolis, Minnesota, 55404, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89102, United States

Location

GSK Investigational Site

Newark, New Jersey, 7102, United States

Location

GSK Investigational Site

New York, New York, 10008, United States

Location

GSK Investigational Site

Rochester, New York, 14604, United States

Location

GSK Investigational Site

Portland, Oregon, 97210, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19107, United States

Location

GSK Investigational Site

Providence, Rhode Island, 02908, United States

Location

GSK Investigational Site

Dallas, Texas, 75208, United States

Location

GSK Investigational Site

Dallas, Texas, 75215, United States

Location

GSK Investigational Site

Dallas, Texas, 75246, United States

Location

GSK Investigational Site

Brussels, 1000, Belgium

Location

GSK Investigational Site

Ottawa, Ontario, K1N 6N5, Canada

Location

GSK Investigational Site

Toronto, Ontario, M4N 3M5, Canada

Location

GSK Investigational Site

Montreal, Quebec, H2L 4P9, Canada

Location

GSK Investigational Site

Montreal, Quebec, H2L 5B1, Canada

Location

GSK Investigational Site

Levallois-Perret, 92300, France

Location

GSK Investigational Site

Lyon, 69288, France

Location

GSK Investigational Site

Nantes, 44093, France

Location

GSK Investigational Site

Paris, 75018, France

Location

GSK Investigational Site

Würzburg, Bavaria, 97080, Germany

Location

GSK Investigational Site

Frankfurt am Main, Hesse, 60590, Germany

Location

GSK Investigational Site

Hanover, Lower Saxony, 30625, Germany

Location

GSK Investigational Site

Brescia, Lombardy, 25125, Italy

Location

GSK Investigational Site

Milan, Lombardy, 20127, Italy

Location

GSK Investigational Site

Milan, Lombardy, 20157, Italy

Location

GSK Investigational Site

Coimbra, 3000-075, Portugal

Location

GSK Investigational Site

Lisbon, 1169-100, Portugal

Location

GSK Investigational Site

Porto, 4200-319, Portugal

Location

GSK Investigational Site

Madrid, 28029, Spain

Location

GSK Investigational Site

Manchester, Lancashire, M8 5RB, United Kingdom

Location

GSK Investigational Site

Brighton, Sussex East, BN2 1ES, United Kingdom

Location

GSK Investigational Site

Birmingham, Warwickshire, B29 6JD, United Kingdom

Location

GSK Investigational Site

London, EC1 7BE, United Kingdom

Location

GSK Investigational Site

London, SW10 9TH, United Kingdom

Location

MeSH Terms

Conditions

Infections; HIV Infections

Interventions

aplaviroc; lamivudine, zidovudine drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• GSK Clinical Trials, MD

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2005
• First Posted: March 1, 2005
• Study Start: January 1, 2005
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2006
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

FR (4); PT (3); US (27); CA (4); GB (5); BE (1); DE (3); IT (3); ES (1)