Tissue Drug Levels of HIV Medications

NCT ID: NCT01490346

Last Updated: 2015-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2014-09-30

Brief Summary

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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

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Conditions

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Human Immunodeficiency Virus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ART treated individuals

Initiation of anti-retroviral therapy

Intervention Type DRUG

Subjects begin taking a preferred initial anti-retroviral regimens as determined by their primary care provider. Intracellular levels of those medications are measured.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timothy Schacker, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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P01AI074340

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0712M22448

Identifier Type: -

Identifier Source: org_study_id

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