Tissue Drug Levels of HIV Medications

Human Immunodeficiency Virus Clinical Trial

Official title:

A Compartmental Analysis of HIV Reservoirs and Immune Reconstitution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01490346
• Other study ID #: 0712M22448
• Secondary ID: P01AI074340
• Status: Completed
• Phase: N/A
• First received: October 24, 2011
• Last updated: June 1, 2015
• Start date: September 2008
• Est. completion date: September 2014

Study information

• Verified date: June 2015
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intracellular antiretroviral drug concentrations		Measured at baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months & 6 months	No
Secondary	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	No

External Links

•   HIV University of Minnesota website