Tissue Drug Levels of HIV Medications

This study is currently recruiting participants.

Verified December 2011 by University of Minnesota - Clinical and Translational Science Institute

First Received on October 24, 2011. Last Updated on December 8, 2011 History of Changes

Sponsor:	University of Minnesota - Clinical and Translational Science Institute
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

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

Condition	Intervention
Human Immunodeficiency Virus	Drug: Atripla (EFV/TDF/FTC); boosted darunavir & tenofovir/FTC; boosted atazanavir & tenofovir/FTC; raltegravir & tenofovir/FTC

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	A Compartmental Analysis of HIV Reservoirs and Immune Reconstitution

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Tenofovir Atazanavir Tenofovir Disoproxil Fumarate Darunavir Atazanavir sulfate Raltegravir Darunavir ethanolate Truvada Atripla Raltegravir potassium

U.S. FDA Resources

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 ]

Estimated Enrollment:	40
Study Start Date:	September 2008
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01490346

Contacts

Contact: Ann Seguin, RN

612-625-7472

segu0017@umn.edu

Locations

United States, Minnesota
University of Minnesota	Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Ann Seguin, RN 612-625-7472 segu0017@umn.edu
Principal Investigator: Timothy W. Schacker, M.D.

Sponsors and Collaborators

University of Minnesota - Clinical and Translational Science Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Principal Investigator:

Timothy Schacker, MD

University of Minnesota - Clinical and Translational Science Institute

More Information

Additional Information:

HIV University of Minnesota website This link exits the ClinicalTrials.gov site

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:	December 8, 2011
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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Tenofovir
Tenofovir disoproxil
Efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination

Atazanavir
Darunavir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
HIV Protease Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on May 23, 2012