Status:
COMPLETED
Pilot Study of a Raltegravir Based NRTI Sparing Regimen
Lead Sponsor:
Yale University
Collaborating Sponsors:
Bristol-Myers Squibb
Merck Sharp & Dohme LLC
Conditions:
Acquired Immune Deficiency Syndrome
AIDS
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This pilot study will provide data on the safety and efficacy of the combination of Raltegravir (RAL) 400mg BID + Atazanavir (ATV) 300 mg BID in Antiretroviral (ARV)-experienced subjects that have a s...
Detailed Description
The purpose of this pilot study is to compare the virological efficacy, as measured by the proportion of patients with plasma HIV-RNA below the limit of detection (\<50 copies/mL), of two ARV regimens...
Eligibility Criteria
Inclusion
- HIV-1 positive
- On stable ARV-therapy for a minimum of 4 months with a HIV viral load of \< 50 copies
- Currently on a N(t)RTI(s) based backbone + PI/r
- No prior history of PI drug resistance (by historical genotype or phenotype)
- Aged \> 18 years of age
- Written informed consent
- Women of childbearing potential (WOCBP) 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 investigational product, in such a manner that the risk of pregnancy is minimized.
Exclusion
- Prior exposure to Raltegravir or Elvitegravir
- A detectable HIV viral load \>50 copies within the last 4 months
- An ARV change within the last 4 months
- History of PI drug resistance
- Prior virologic failure on an ATV containing regimen
- Prior history of intolerance to ATV
- Pregnant or nursing mothers
- Pre-existing grade 3 or above laboratory toxicity except for lipids:
- Absolute neutrophil count (ANC) \< 750 cells/mL.
- Hemoglobin \< 8.0 g/dL.
- Platelet count \< 50 000 cells/mL.
- AST, ALT and alkaline phosphatase \> 5 x ULN.
- Serum bilirubin \> 5 x ULN.
- calculated creatinine clearance of \<50mL/min/1.73m2
- Patients with chronic active hepatitis B infection defined by positive serum Hbs antigen
- Use of any prohibited medications and/or the use of proton pump inhibitors in ATV plus RAL containing regimens)
- Patients with current alcohol or illicit substance use that in judgment of investigator makes study adherence unlikely
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00814879
Start Date
May 1 2009
End Date
November 1 2013
Last Update
February 4 2016
Active Locations (5)
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1
Yale University School of Medicine
New Haven, Connecticut, United States, 06504
2
Saint Raphael Healthcare System
New Haven, Connecticut, United States, 06511
3
Waterbury Hospital
Waterbury, Connecticut, United States, 06721
4
VA CT Healthcare Systems
West Haven, Connecticut, United States, 06516