Tissue Drug Levels of HIV Medications

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01490346
First received: October 24, 2011
Last updated: September 13, 2013
Last verified: September 2013

October 24, 2011
September 13, 2013
September 2008
December 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01490346 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Tissue Drug Levels of HIV Medications
A Compartmental Analysis of HIV Reservoirs and Immune Reconstitution

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Blood & lymphatic tissue.

Non-Probability Sample

HIV-positive individuals beginning anti-retroviral treatment.

Human Immunodeficiency Virus
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.
ART treated individuals
Intervention: Drug: Initiation of anti-retroviral therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Ann Thorkelson, RN 612-625-7472 segu0017@umn.edu
United States
 
NCT01490346
0712M22448, P01AI074340
No
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Timothy Schacker, MD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP