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

Terminated

• Conditions: HIV Infection

• Registration Number: NCT00321438
• Lead Sponsor: GlaxoSmithKline

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2006-05-01
• Study First Submitted QC: 2006-05-02
• Study First Posted: 2006-05-03
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-15
• Last Update Posted: 2009-05-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 150

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:

• 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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Hampton, Virginia, United States