Tissue Drug Levels of HIV Medications
This study is ongoing, but not recruiting participants.
Sponsor:
University of Minnesota - Clinical and Translational Science Institute
Collaborator:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01490346
First received: October 24, 2011
Last updated: September 5, 2014
Last verified: September 2014
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Human Immunodeficiency Virus |
Drug: Initiation of anti-retroviral therapy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Compartmental Analysis of HIV Reservoirs and Immune Reconstitution |
Resource links provided by NLM:
Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Blood & lymphatic tissue.
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
HIV-positive individuals beginning anti-retroviral treatment.
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01490346
Please refer to this study by its ClinicalTrials.gov identifier: NCT01490346
Locations
| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
| Principal Investigator: | Timothy Schacker, MD | University of Minnesota - Clinical and Translational Science Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Minnesota - Clinical and Translational Science Institute |
| ClinicalTrials.gov Identifier: | NCT01490346 History of Changes |
| Other Study ID Numbers: | 0712M22448, P01AI074340 |
| Study First Received: | October 24, 2011 |
| Last Updated: | September 5, 2014 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
|
HIV 1 Pharmacokinetics Drug levels Treatment naive |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Immune System Diseases Lentivirus Infections RNA Virus Infections |
Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Virus Diseases |
ClinicalTrials.gov processed this record on February 25, 2015