Status:
COMPLETED
BATAR: Individuals Currently Taking Boosted Atazanavir as Part of an HIV Treatment Regimen Will be Evaluated to See if Substituting Raltegravir for Nucleoside Transcriptase Inhibitors Will be Safe and Well Tolerated.
Lead Sponsor:
Community Research Initiative of New England
Collaborating Sponsors:
Bristol-Myers Squibb
Merck Sharp & Dohme LLC
Conditions:
HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this Phase IV pilot study is to evaluate the safety, tolerability, and satisfaction of a nucleoside analog reverse-transcriptase inhibitors (NRTI)sparing regimen for participants fully ...
Eligibility Criteria
Inclusion
- HIV-1 infection
- Treatment with a stable antiretroviral regiment containing boosted atazanavir, tenofovir and emtricitabine at screen and for at least 90 days prior to screening
- No plan to make changes to HIV treatment regimen (other than those required by the study) in the next 48 weeks
- Undetectable HIV RNA at screening AND no HIV RNA\>200 copies during the 180 day period prior to screening
- CD4 count\>200
- No evidence of resistance to any of the drugs in any of the 3 arms, if prior resistance tests are available
- Subjects who, in the opinion of their treating physicians, would be candidates to switch antiretroviral medications
- Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of study drug
- Ability and willingness to provide written informed consent and comply with protocol requirements
Exclusion
- Prior exposure to raltegravir or elvitegravir
- Women who are pregnant, breast-feeding, or with a positive pregnancy test
- Sexually active fertile men not using effective birth control if their female partners are of child-bearing potential
- Women of child-bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of study drug
- Life expectancy less than 6 months
- Presence of any currently active AIDS defining conditions with the exception of stable cutaneous Kaposi's sarcoma
- Treatment with proton-pump inhibitor or H2-receptor antagonist
- ECG demonstrating atrioventricular block, prolonged QRS interval greater than 12 ms, or known complete bundle branch block
- Acute or chronic hepatitis B infection as evidenced by presence of hepatitis B surface antigen and absence of hepatitis B surface antibody
- Clinical or laboratory evidence of significantly decreased hepatic function of decompensation irrespective of liver enzyme levels
- Prisoners or subjects who are involuntarily incarcerated
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00931801
Start Date
December 1 2009
End Date
March 1 2012
Last Update
July 21 2017
Active Locations (9)
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1
Spectrum Medical Group
Phoenix, Arizona, United States, 85012
2
AIDS Healthcare Foundation
Los Angeles, California, United States, 90028
3
Denver Public Health
Denver, Colorado, United States, 80204
4
Whitman-Walker Clinic
Washington D.C., District of Columbia, United States, 20009