Observational Study of HIV-Infected Subjects With X4-Tropic or Non-Phenotypeable Virus (NCT00321438) | Clinical Trial Compass
TerminatedNot Applicable
Observational Study of HIV-Infected Subjects With X4-Tropic or Non-Phenotypeable Virus
United States150 participantsStarted 2005-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.