Pilot Study of a Raltegravir Based NRTI Sparing Regimen

Completed · Not applicable

Conditions studied: Acquired Immune Deficiency Syndrome, AIDS, Human Immunodeficiency Virus, HIV Infections

In brief

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.

Key facts

Study ID

NCT00814879

Run by

Yale University

People needed

60

Starts

2009-05-01

Expected to finish

2013-11-01

Last updated by the study team

2016-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Yale University School of Medicine — New Haven, Connecticut, United States
• Saint Raphael Healthcare System — New Haven, Connecticut, United States
• Waterbury Hospital — Waterbury, Connecticut, United States
• VA CT Healthcare Systems — West Haven, Connecticut, United States
• Comprehensive Care Center, Inc (dba Community AIDS Network) — Sarasota, Florida, United States

Full record on ClinicalTrials.gov

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