Study Of Chemokine Coreceptor 5 (CCR5) Antagonist GW873140 In R5-Tropic Treatment-Experienced HIV-Infected Subjects

NCT00197145 | Terminated Phase 3 Results

• 1 other identifier: CCR102709
• Study Type: interventional
• Target: 24
• Locations: 3 countries
• Sites: 55

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of the CCR5 antagonist GW873140 or placebo in combination with an optimized background regimen in treatment-experienced HIV-infected subjects with R5-tropic virus

Conditions

Infection, Human Immunodeficiency Virus I

Keywords

HIV-1 GW873140 CCR5 antagonist experienced

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Plasma HIV-1 RNA <400 Copies Per Milliliter (Copies /mL) at Week 24 and 48

  Assessment for plasma HIV-1 RNA was done at Week 24 and also planned at Week 48 by polymerase chain reaction (PCR) analysis. Data is reported for number of participants with plasma HIV-1 RNA \<400 copies/mL at Week 24. Data was not collected for Week 48 due to early termination of the study.

  Week 24

• Average Area Under the Curve Minus Baseline (AAUCMB) of Plasma HIV-1 RNA Through the Entire Study Period

  The area under the plasma HIV-1 RNA curve (AUC) was computed using the trapezoidal rule for all assessments (scheduled and unscheduled) at their actual time points. Baseline was defined as the mean of the Baseline (Day 1) and pre-treatment visit values. Participants without a Baseline assessment was removed from the analysis. The AAUCMB was computed by the AUC divided by the duration of the profile (i.e., the number of days on randomized therapy) minus the Baseline measurement. Data is reported up to Week 40 only due to early termination of the study.

  Up to Week 40

• Number of Participants With >= 1.0 log10 Copies/mL Decrease in Plasma HIV-1 RNA From Baseline Over Time

  The plasma HIV-1 RNA polymerase chain reaction (PCR) assessments were planned at pre-Baseline (between 1 and 14 days prior to Day 1), up to Week 12 Follow- up of the Randomized Phase, up to Week 12 Follow-up of the Open Labeled Non-Randomized phase and every 6 months Follow-up of off study drug/on study phase, however the study was early terminated at Week 40. Baseline was defined as the mean of the Baseline (Day 1) and pre-treatment visit values.

  Day 1 up to Week 12 Follow-up of the Randomized Treatment phase, up to Week 12 Follow-up of the Open Labeled Non-Randomized phase and every 6 months Follow-up of off study drug/on study phase

Secondary Outcomes (25)

• Number of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 24 and 48

  Week 24

• Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), Death, Drug-related AE and AE Leading to Treatment Discontinuation

  Up to Follow-up (Week 52)

• Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline

  Up to Week 40

• Change From Baseline in Chemistry Parameters of ALT, ALP, AST and CK During the Randomized Treatment Phase

  Baseline (Day 1), Week 12 and Week 24

• Change From Baseline in Chemistry Parameters of CO2 Content/Bicarbonate, Chloride, Cholesterol, Glucose, High DL Cholesterol, LDL Cholesterol, Triglycerides, Potassium, Urea and Sodium During the Randomized Treatment Phase

  Baseline (Day 1), Week 12 and Week 24

Study Arms (1)

GW873140

EXPERIMENTAL

Drug: GW873140

Interventions

GW873140 DRUG

400 mg twice daily

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.
• Screening viral load at least 5000copies/mL.
• R5-tropic only virus at screening.
• Total prior antiretroviral experience of at least 3 months and documented resistance to at least one drug in each of the following classes: nucleoside reverse transcriptase inhibitors (NRTI), non-nucleoside reverse transcriptase inhibitors (NNRTI), and protease inhibitors (PI).
• Stable antiretroviral regimen (or no antiretroviral treatment) for at least 4 weeks before screening.
• Able to receive a ritonavir-boosted protease inhibitor during treatment studies.
• Women of childbearing potential must use specific forms of contraception.

You may not qualify if:

• Acute laboratory abnormalities.
• History of pancreatitis or hepatitis, hepatitis B or hepatitis C coinfection, or any chronic liver disease. Screening liver function tests will be used to determine eligibility.
• R5/X4-tropic, X4-tropic only, or non-phenotypeable virus at screening.
• Changes to antiretroviral therapy from 4 weeks prior to screening until Day 1 of treatment study.
• Pregnancy or breastfeeding women.
• Recent participation in an experimental drug trial.
• Prior use of a CCR5 or CXCR4 antagonist.
• Significant ECG abnormalities or significant history of active pancreatitis, hepatitis, opportunistic infections, malabsorption disorders, cancer, or severe illness.
• Current use of certain medications may exclude participation in this study.
• Additional qualifying criteria and laboratory test requirements to be assessed by study physician.

Sponsors & Collaborators

• ViiV Healthcare: lead
• GlaxoSmithKline: collaborator

Study Sites (55)

GSK Investigational Site

Birmingham, Alabama, 35294, United States

Location

GSK Investigational Site

Beverly Hills, California, 90210, United States

Location

GSK Investigational Site

Fountain Valley, California, 92708, United States

Location

GSK Investigational Site

Laguna Beach, California, 92651, United States

Location

GSK Investigational Site

Long Beach, California, 90813, United States

Location

GSK Investigational Site

Los Angeles, California, 90046, United States

Location

GSK Investigational Site

Los Angeles, California, 90069, United States

Location

GSK Investigational Site

Oakland, California, 94609, United States

Location

GSK Investigational Site

San Francisco, California, 94114, United States

Location

GSK Investigational Site

Tarzana, California, 91356, United States

Location

GSK Investigational Site

Glastonbury, Connecticut, 06033, United States

Location

GSK Investigational Site

Norwalk, Connecticut, 06851, United States

Location

GSK Investigational Site

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

Location

GSK Investigational Site

Washington D.C., District of Columbia, 20037, United States

Location

GSK Investigational Site

Fort Lauderdale, Florida, 33306, United States

Location

GSK Investigational Site

Fort Lauderdale, Florida, 33308, United States

Location

GSK Investigational Site

Fort Myers, Florida, 33901, United States

Location

GSK Investigational Site

Key West, Florida, 33040, United States

Location

GSK Investigational Site

Miami, Florida, 33136, United States

Location

GSK Investigational Site

Oakland Park, Florida, 33334, United States

Location

GSK Investigational Site

Orlando, Florida, 32804, United States

Location

GSK Investigational Site

Plantation, Florida, 33317, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30308/30309, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30339, United States

Location

GSK Investigational Site

Decatur, Georgia, 30033, United States

Location

GSK Investigational Site

Chicago, Illinois, 60613, United States

Location

GSK Investigational Site

Chicago, Illinois, 60657, United States

Location

GSK Investigational Site

Wichita, Kansas, 67214, United States

Location

GSK Investigational Site

New Orleans, Louisiana, 70127-0800, United States

Location

GSK Investigational Site

Portland, Maine, 04102, United States

Location

GSK Investigational Site

Baltimore, Maryland, 21201, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02215, United States

Location

GSK Investigational Site

Minneapolis, Minnesota, 55404, United States

Location

GSK Investigational Site

St Louis, Missouri, 63108, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89102, United States

Location

GSK Investigational Site

East Orange, New Jersey, 07018, United States

Location

GSK Investigational Site

Hillsborough, New Jersey, 08844, United States

Location

GSK Investigational Site

Newark, New Jersey, 07102, United States

Location

GSK Investigational Site

Mount Vernon, New York, 10550, United States

Location

GSK Investigational Site

New York, New York, 10014, United States

Location

GSK Investigational Site

Charlotte, North Carolina, 28209, United States

Location

GSK Investigational Site

Akron, Ohio, 44304, United States

Location

GSK Investigational Site

Portland, Oregon, 97209, United States

Location

GSK Investigational Site

Portland, Oregon, 97219, United States

Location

GSK Investigational Site

Columbia, South Carolina, 29206-4713, United States

Location

GSK Investigational Site

Austin, Texas, 78746, United States

Location

GSK Investigational Site

Dallas, Texas, 75246, United States

Location

GSK Investigational Site

Houston, Texas, 77027, United States

Location

GSK Investigational Site

Annandale, Virginia, 22003, United States

Location

GSK Investigational Site

Hampton, Virginia, 23666, United States

Location

GSK Investigational Site

Lynchburg, Virginia, 24501, United States

Location

GSK Investigational Site

Spokane, Washington, 99204, United States

Location

GSK Investigational Site

Toronto, Ontario, M5B 1L6, Canada

Location

GSK Investigational Site

Ponce, 00731, Puerto Rico

Location

GSK Investigational Site

San Juan, 00910, Puerto Rico

Location

MeSH Terms

Conditions

Infections

Interventions

aplaviroc

Limitations and Caveats

Study was early terminated prior to the completion of enrollment due to treatment-emergent hepatotoxicity that occurred among some participants receiving APL.

Results Point of Contact

• Title: GSK Response Center
• Organization: ViiV Healthcare

866-435-7343

Study Officials

• GSK Clinical Trials

  ViiV Healthcare

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: July 21, 2005
• Primary Completion: September 11, 2007
• Study Completion: September 11, 2007
• Last Updated: November 2, 2018
• Results First Posted: November 2, 2018

Record last verified: 2017-08

Locations

CA (1); US (52); PR (2)