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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
  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: 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:

MedlinePlus related topics: HIV/AIDS
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)
Groups/Cohorts Assigned Interventions
Atripla 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
Truvada/Reyataz/Norvir 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
Truvada/Prezista/Norvir 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
Raltegravir/Truvada 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

  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
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: August 30, 2012
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
Ritonavir
Atazanavir
Darunavir
Tenofovir
 Tenofovir disoproxil
Efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on June 13, 2013