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Completed

NCT Number: NCT01490346

Tissue Drug Levels of HIV Medications

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.

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Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Initiation of anti-retroviral therapy

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

A Compartmental Analysis of HIV Reservoirs and Immune Reconstitution

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Dec 13, 2011
Registry last updated
Jun 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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