NCT00197197

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/X4-tropic virus

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_3

Geographic Reach
2 countries

12 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

March 29, 2011

Status Verified

March 1, 2011

Enrollment Period

3 months

First QC Date

September 12, 2005

Last Update Submit

March 28, 2011

Conditions

HIV Infection

Keywords

HIV-1 GW873140 CCR5 antagonist treatment experienced

Outcome Measures

Primary Outcomes (1)

  • HIV viral load response at 24 and 48 weeks.

    24 and 48 weeks

Secondary Outcomes (1)

  • Safety and tolerability, change in T-cell count, disease progression, viral resistance,tropism at failure, pharmacokinetics, health outcomes.Liver tests will be done every 2 weeks for 24 weeks.

    every 2 weeks for 24 weeks

Interventions

GW873140DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV-infected.
  • Screening viral load at least 5000copies/mL.
  • R5/X4-tropic virus at screening.
  • Total prior antiretroviral experience of at least 3 months.
  • 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-tropic only.
  • X4-tropic only.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

GSK Investigational Site

Los Angeles, California, 90046, United States

Location

GSK Investigational Site

Norwalk, Connecticut, 06851, United States

Location

GSK Investigational Site

Fort Lauderdale, Florida, 33308, United States

Location

GSK Investigational Site

Hollywood, Florida, 33020, United States

Location

GSK Investigational Site

Plantation, Florida, 33317, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30339, United States

Location

GSK Investigational Site

Chicago, Illinois, 60657, United States

Location

GSK Investigational Site

New Orleans, Louisiana, 70127-0800, United States

Location

GSK Investigational Site

Baltimore, Maryland, 21201, United States

Location

GSK Investigational Site

Newark, New Jersey, 07102, United States

Location

GSK Investigational Site

Houston, Texas, 77027, United States

Location

GSK Investigational Site

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

HIV Infections

Interventions

aplaviroc

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • GSK Clinical Trials, Ph.D.

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

July 1, 2005

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

March 29, 2011

Record last verified: 2011-03

Locations

US(11)BE(1)