Human Immunodeficiency Virus
Conditions
Keywords
HIV 1, Pharmacokinetics, Drug levels, Treatment naive
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.
Interventions
DRUGInitiation of anti-retroviral therapy
Subjects begin taking a preferred initial anti-retroviral regimens as determined by their primary care provider. Intracellular levels of those medications are measured.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
University of Minnesota
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
* Contraindications to surgical & endoscopy procedures (as judged by PI) * Psychiatric or psychological illness that would make adherence to protocol procedures unlikely * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intracellular antiretroviral drug concentrations | Measured at baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months & 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed