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Tissue Drug Levels of HIV Medications

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01490346
Recruitment Status : Completed
First Posted : December 13, 2011
Last Update Posted : June 3, 2015
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of Minnesota

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 get into the lymphatic tissue where HIV persists.

Condition or disease Intervention/treatment
Human Immunodeficiency Virus Drug: Initiation of anti-retroviral therapy

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Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Compartmental Analysis of HIV Reservoirs and Immune Reconstitution
Study Start Date : September 2008
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Medicines

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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples Without DNA
Blood & lymphatic tissue.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV-positive individuals beginning anti-retroviral treatment.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01490346

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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: Timothy Schacker, MD University of Minnesota
Additional Information:
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT01490346    
Other Study ID Numbers: 0712M22448
P01AI074340 ( U.S. NIH Grant/Contract )
First Posted: December 13, 2011    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015
Keywords provided by University of Minnesota:
Drug levels
Treatment naive
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents