Status:
COMPLETED
Raltegravir + Lopinavir/Ritonavir or Emtricitabine/Tenofovir for HIV Treatment Naive Subjects
Lead Sponsor:
Margaret A. Fischl, M.D.
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A prospective, randomized, open-label pilot study to assess virologic suppression and immunologic recovery associated with a two-drug antiretroviral regimen of Raltegravir and the protease inhibitor l...
Detailed Description
A009 is a prospective, randomized, open-label pilot study to assess virologic suppression and immune recovery rates associated with a two-drug potent antiretroviral regimen of raltegravir and the prot...
Eligibility Criteria
Inclusion
- Documented HIV Infection
- Genotypic resistance without major resistance mutations within 30 days
- Antiretroviral drug-naïve
- Screening HIV-1 RNA ≥5000
- Women of reproductive potential
- Negative pregnancy test within 48 hours
Exclusion
- Acute or recent HIV-1 infection
- Currently breast feeding
- Use of immunomodulators
- Evidence of major resistance mutations
- HBsAg positive
- Acute hepatitis of any etiology or clinically significant liver disease
- Current imprisonment or involuntary incarceration
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00654147
Start Date
April 1 2008
End Date
January 1 2012
Last Update
August 3 2015
Active Locations (1)
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1
University of Miami AIDS Clinical Research Unit
Miami, Florida, United States, 33136