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Observational Study of HIV-In...

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

Last Updated: 2009-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infection

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers