Status:
TERMINATED
Addition of Raltegravir to Established Antiretroviral Suppressive Therapy
Lead Sponsor:
University of Miami
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HIV
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
This is a single-center, open-label, double-arm, crossover study which will include approximately 40 HIV-infected subjects on an established suppressive HAART for at least 2 years with evidence of und...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01245101
Start Date
November 1 2010
End Date
May 1 2013
Last Update
December 23 2016
Active Locations (1)
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1
Infectious Diseases Research Unit, University of Miami Miller School of Medicine
Miami, Florida, United States, 33136