Tissue Drug Levels of HIV Medications

NCT01490346 | Completed

• 2 other identifiers: 0712M22448P01AI074340
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus

Keywords

HIV 1; Pharmacokinetics; Drug levels; Treatment naive

Outcome Measures

Primary Outcomes (1)

• Intracellular antiretroviral drug concentrations

  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

  Measured at baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, & 6 months

Study Arms (1)

ART treated individuals

Drug: Initiation of anti-retroviral therapy

Interventions

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.

ART treated individuals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-positive individuals beginning anti-retroviral treatment.

You may qualify if:

• 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

You may not qualify if:

• Contraindications to surgical \& endoscopy procedures (as judged by PI)
• Psychiatric or psychological illness that would make adherence to protocol procedures unlikely
• Pregnancy

Sponsors & Collaborators

• University of Minnesota: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood \& lymphatic tissue.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Timothy Schacker, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: December 13, 2011
• Study Start: September 1, 2008
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 3, 2015

Record last verified: 2015-06

Locations

US (1)