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TerminatedNCT00321438Updated May 18, 2009

Observational Study of HIV-Infected Subjects With X4-Tropic or Non-Phenotypeable Virus

An observational study in HIV Infection, sponsored by GlaxoSmithKline. Terminated at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-05-18.

Sponsored by GlaxoSmithKline · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to measure viral tropism over time in subjects with X4-tropic or non-phenotypeable virus while receiving standard of care therapy. This is an observational study. No investigational treatment will be administered through this study.

02

Conditions studied

  • HIV Infection

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Keywords

  • HIV-1
  • GW873140
  • CCR5 antagonist
  • experienced
  • treatment experienced
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 150 is below the median of 200 across 713 observational studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • HIV-infected.
  • Screening viral load at least 5000copies/mL.
  • X4-tropic only or non-phenotypeable 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: NRTI, NNRTI, and 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.

Exclusion criteria

Exclusion criteria:

  • R5-tropic only or R5/X4-tropic virus at screening, changes to antiretroviral therapy from 4 weeks prior to screening until Day 1 of observational study.
  • Pregnant or breastfeeding women.
  • Significant ECG abnormalities or significant history of active pancreatitis, hepatitis, opportunistic infections, cancer, or severe illness.
  • Current use of certain medications may exclude participation in this study.
  • Additional qualifying criteria and laboratory test requirements to be determined by study physician.
05

Study design

Time perspective
Prospective
Enrollment
150 participants
06

Study locations

15 sites
  • GSK Investigational Site
    Los Angeles, California 90069, United States
  • GSK Investigational Site
    Tarzana, California 91356, United States
  • GSK Investigational Site
    Washington, District of Columbia 20037, United States
  • GSK Investigational Site
    Fort Myers, Florida 33901, United States
  • GSK Investigational Site
    Key West, Florida 33040, United States
  • GSK Investigational Site
    Miami, Florida 33136, United States
  • GSK Investigational Site
    Plantation, Florida 33317, United States
  • GSK Investigational Site
    Atlanta, Georgia 30308/30309, United States
  • GSK Investigational Site
    Atlanta, Georgia 30339, United States
  • GSK Investigational Site
    Decatur, Georgia 30033, United States
  • GSK Investigational Site
    Baltimore, Maryland 21201, United States
  • GSK Investigational Site
    East Orange, New Jersey 07018, United States
  • GSK Investigational Site
    New York, New York 10014, United States
  • GSK Investigational Site
    Charlotte, North Carolina 28209, United States
  • GSK Investigational Site
    Hampton, Virginia 23666, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00321438
Lead sponsor
GlaxoSmithKline
First posted
May 3, 2006
Start date
Jul 2005
Last update
May 18, 2009

Study contacts

GSK Clinical Trials, MD
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2009. You cannot join it, but the record below documents what was studied.

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