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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01245101
Other study ID # UM 20100499
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received November 19, 2010
Last updated June 1, 2015
Start date November 2010
Est. completion date October 2015

Study information

Verified date June 2015
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This study will examine whether intensification with raltegravir of a suppressive antiretroviral regimen in HIV infected patients with poor immune restoration has a beneficial effect on cryptic viral replication and the immune system. Specifically, the investigators will examine the effect that raltegravir intensification of ART has on episomal cDNA frequencies, immune activation, CD4+ cell counts and apoptosis, and markers of microbial translocation.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Raltegravir
Raltegravir 400 mg twice daily in addition to subject's antiretroviral therapy.
Raltegravir
Raltegravir 400 mg twice daily in addition to subject's antiretroviral therapy.

Locations

Country Name City State
United States Infectious Diseases Research Unit, University of Miami Miller School of Medicine Miami Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Miami Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Episomal HIV cDNA formation These are linear viral cDNAs that are subsequently circularized by the DNA repair apparatus of the host cell to form episomes. They are markers of ongoing viral replication. 40 weeks No
Secondary Markers of immune activation Flow cytometry will be performed in whole blood for analysis of markers CD3, CD4, CD8, HLA-DR and CD38 by standard methodology using a LSR-II flow cytometer. Percentage and absolute counts of CD3+CD4+T cells, and frequencies of CD3+CD8+ subset, CD8+CD38+; CD8+ HLA-DR+ and CD8+HLADR+ CD38+ cells will be determined. 40 weeks No
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