Discontinuation of Antiretroviral Therapy in Patients With Asymptomatic HIV Infection
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|ClinicalTrials.gov Identifier: NCT00050284|
Recruitment Status : Completed
First Posted : December 4, 2002
Last Update Posted : November 9, 2010
|Condition or disease|
Patients who can discontinue ART without a significant loss of virologic or immunologic control and without an increase in clinical events may be spared the expense and adverse effects of treatment. However, the consequences of treatment discontinuation in patients with asymptomatic HIV infections are not well understood. This study will follow the clinical and immunologic progression of HIV infection in patients who have low HIV viral load and preserved CD4+ cell counts at the time ART is stopped.
Patients will fast for at least 8 hours prior to the first study visit. At this visit, blood will be drawn and body measurements will be taken. Patients will then discontinue their ART. Patients taking nonnucleoside reverse transcriptase inhibitors (NNRTIs) will stop taking NNRTIs 48 hours before withdrawing their other ART drugs. Study visits will occur every 4 to 8 weeks for the first year, then every 12 weeks for the second year. Blood will be taken at most visits, and patients will be asked to fast for at least 8 hours prior to Week 12 and 24 visits and again every 6 months. Patients who reinitiate ART for any reason will be registered to Step 2 and followed for 24 weeks.
|Study Type :||Observational|
|Enrollment :||158 participants|
|Official Title:||Predictors of Immunologic and Clinical Progression in Subjects With CD4+ Cell Counts Greater Than 350 Cells/mm3 Who Discontinue Antiretroviral Therapy|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00050284
|Study Chair:||Daniel J. Skiest, M. D.||University of Texas Southwestern Medical Center|