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NCT00321438 Clinical Trial

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

HIV Infection Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00321438
Other study ID # CCR104629
Secondary ID
Status Terminated
Phase N/A
First received May 1, 2006
Last updated May 15, 2009
Start date July 2005

Study information
Verified date May 2009
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 150
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States GSK Investigational Site Atlanta Georgia
United States GSK Investigational Site Atlanta Georgia
United States GSK Investigational Site Baltimore Maryland
United States GSK Investigational Site Charlotte North Carolina
United States GSK Investigational Site Decatur Georgia
United States GSK Investigational Site East Orange New Jersey
United States GSK Investigational Site Fort Myers Florida
United States GSK Investigational Site Hampton Virginia
United States GSK Investigational Site Key West Florida
United States GSK Investigational Site Los Angeles California
United States GSK Investigational Site Miami Florida
United States GSK Investigational Site New York New York
United States GSK Investigational Site Plantation Florida
United States GSK Investigational Site Tarzana California
United States GSK Investigational Site Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

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