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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


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
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