Tissue Drug Levels of HIV Medications
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ClinicalTrials.gov Identifier: NCT01490346 |
Recruitment Status :
Completed
First Posted : December 13, 2011
Last Update Posted : June 3, 2015
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Condition or disease | Intervention/treatment |
---|---|
Human Immunodeficiency Virus | Drug: Initiation of anti-retroviral therapy |
Study Type : | Observational |
Actual Enrollment : | 22 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A Compartmental Analysis of HIV Reservoirs and Immune Reconstitution |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | September 2014 |
Actual Study Completion Date : | September 2014 |

Group/Cohort | Intervention/treatment |
---|---|
ART treated individuals |
Drug: Initiation 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. |
- Intracellular antiretroviral drug concentrations [ Time Frame: Measured at baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months & 6 months ]
- Evidence of HIV replication in blood and lymphoid tissue [ Time Frame: Measured at baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, & 6 months ]
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

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): NCT01490346
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 |
Principal Investigator: | Timothy Schacker, MD | University of Minnesota |
Responsible Party: | University of Minnesota |
ClinicalTrials.gov Identifier: | NCT01490346 |
Other Study ID Numbers: |
0712M22448 P01AI074340 ( U.S. NIH Grant/Contract ) |
First Posted: | December 13, 2011 Key Record Dates |
Last Update Posted: | June 3, 2015 |
Last Verified: | June 2015 |
HIV 1 Pharmacokinetics Drug levels Treatment naive |
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Immune System Diseases Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Slow Virus Diseases Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |