Tissue Drug Levels of HIV Medications

This study is currently recruiting participants.

Verified August 2012 by University of Minnesota - Clinical and Translational Science Institute

Sponsor:

Collaborator:

National Institute of Allergy and Infectious Diseases (NIAID)

Information provided by (Responsible Party):

University of Minnesota - Clinical and Translational Science Institute

ClinicalTrials.gov Identifier:

NCT01490346

First received: October 24, 2011

Last updated: August 30, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 24, 2011

Last Updated Date

August 30, 2012

Start Date ^ICMJE

September 2008

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01490346 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Tissue Drug Levels of HIV Medications

Official Title ^ICMJE

A Compartmental Analysis of HIV Reservoirs and Immune Reconstitution

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 do not completely stop the virus from making additional copies of HIV.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

HIV-positive individuals beginning anti-retroviral treatment.

Condition ^ICMJE

Human Immunodeficiency Virus

Intervention ^ICMJE

Drug: Atripla (EFV/TDF/FTC); boosted darunavir & tenofovir/FTC; boosted atazanavir & tenofovir/FTC; raltegravir & tenofovir/FTC

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

Other Names:

Atripla
Norvir
Reyataz
Truvada
Prezista
Isentress

Study Group/Cohort (s)

Atripla
Intervention: Drug: Atripla (EFV/TDF/FTC); boosted darunavir & tenofovir/FTC; boosted atazanavir & tenofovir/FTC; raltegravir & tenofovir/FTC
Truvada/Reyataz/Norvir
Intervention: Drug: Atripla (EFV/TDF/FTC); boosted darunavir & tenofovir/FTC; boosted atazanavir & tenofovir/FTC; raltegravir & tenofovir/FTC
Truvada/Prezista/Norvir
Intervention: Drug: Atripla (EFV/TDF/FTC); boosted darunavir & tenofovir/FTC; boosted atazanavir & tenofovir/FTC; raltegravir & tenofovir/FTC
Raltegravir/Truvada
Intervention: Drug: Atripla (EFV/TDF/FTC); boosted darunavir & tenofovir/FTC; boosted atazanavir & tenofovir/FTC; raltegravir & tenofovir/FTC

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2013

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ann Seguin, RN

612-625-7472

segu0017@umn.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01490346

Other Study ID Numbers ^ICMJE

0712M22448, P01AI074340

Has Data Monitoring Committee

Responsible Party

University of Minnesota - Clinical and Translational Science Institute

Study Sponsor ^ICMJE

University of Minnesota - Clinical and Translational Science Institute

Collaborators ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators ^ICMJE

Principal Investigator:

Timothy Schacker, MD

University of Minnesota - Clinical and Translational Science Institute

Information Provided By

University of Minnesota - Clinical and Translational Science Institute

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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