Pilot Study of a Raltegravir Based NRTI Sparing Regimen

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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 suppressed HIV viral load on a Ritonavir (RTV) boosted Protease Inhibitor (PI) based regimen who are then switched to a regimen of RAL 400mg BID +ATV 300mg BID.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborators: Bristol-Myers Squibb; Merck Sharp & Dohme Corp.
• Treatments: Atazanavir Sulfate; Raltegravir Potassium

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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