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

Prospective, Observational Study of Subjects With CXCR4-Tropic or Non-Phenotypeable HIV to Assess Changes in Tropism Over Time

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00321438

Enrollment

150

Registered

2006-05-03

Start date

2005-07-31

Completion date

Unknown

Last updated

2009-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Keywords

HIV-1, GW873140, CCR5 antagonist, experienced, treatment experienced

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Countries

United States

Outcome results