Tissue Drug Levels of HIV Medications

June 1, 2015 updated by: University of Minnesota

A Compartmental Analysis of HIV Reservoirs and Immune Reconstitution

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

HIV-positive individuals beginning anti-retroviral treatment.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Measured at baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months & 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Measured at baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, & 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Timothy Schacker, MD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

October 24, 2011

First Submitted That Met QC Criteria

December 8, 2011

First Posted (Estimate)

December 13, 2011

Study Record Updates

Last Update Posted (Estimate)

June 3, 2015

Last Update Submitted That Met QC Criteria

June 1, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0712M22448
  • P01AI074340 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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