Addition of Raltegravir to Established Antiretroviral Suppressive Therapy
Stopped early · Phase 4
Conditions studied: HIV
In brief
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.
Key facts
- Study ID
- NCT01245101
- Run by
- University of Miami
- People needed
- 15
- Starts
- 2010-11-01
- Expected to finish
- 2013-05-01
- Last updated by the study team
- 2016-12-23
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- To qualify for this study, participants will need to have:
- At least 18 years of age
- Documented HIV-1 infection
- CD4+ count <350 cells/mm3 at the time of enrollment or CD4+ count increase of <100 cells/mm3 within the past 2 years
- Plasma viral load <400 copies/ml at all testing time points within the preceding 2 years AND <50 copies/ml by RT-PCR or <75 copies/ml by bDNA at the 2 testing time points immediately preceding enrollment into the study
You may not qualify if…
- To qualify for this study, patients must not meet any of the following exclusion criteria:
- Pregnancy or breast-feeding
- Prior use of raltegravir at any time in the past
- Use of any investigational, immunomodulatory, immunosuppressive agents within 90 days prior or during this study
- Alcohol or substance abuse that in the opinion of the investigator might interfere with patient compliance or safety
- Any condition or pre-study laboratory abnormality that in the opinion of the investigator might interfere with patient compliance or safety
Where it is running
- Infectious Diseases Research Unit, University of Miami Miller School of Medicine — Miami, Florida, United States
Full record on ClinicalTrials.gov
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