Tissue Drug Levels of HIV Medications
Completed
- Conditions
- Human Immunodeficiency Virus
- Interventions
- Drug: Initiation of anti-retroviral therapy
- Registration Number
- NCT01490346
- Lead Sponsor
- University of Minnesota
- Brief Summary
The aim of this study is to find out why HIV continues to make copies in people taking HIV drugs. The investigators want to know if the medications most people use to treat HIV get into the lymphatic tissue where HIV persists.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
- HIV+
- Treatment naive or >30 days off ARV therapy
- Documented sensitivity to prescribed antiretrovirals
- Age ≥ 18 years
- Negative pregnancy test for eligible women of childbearing potential
- Ready to start ARV therapy
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Exclusion Criteria
- Contraindications to surgical & endoscopy procedures (as judged by PI)
- Psychiatric or psychological illness that would make adherence to protocol procedures unlikely
- Pregnancy
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ART treated individuals Initiation of anti-retroviral therapy -
- Primary Outcome Measures
Name Time Method Intracellular antiretroviral drug concentrations Measured at baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months & 6 months
- Secondary Outcome Measures
Name Time Method Evidence of HIV replication in blood and lymphoid tissue Measured at baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, & 6 months
Trial Locations
- Locations (1)
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States