Pilot Study of a Raltegravir Based NRTI Sparing Regimen

NCT00814879 | Completed Results

• 2 other identifiers: 0811004448Yale-No Nukes
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

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 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.

Conditions

Acquired Immune Deficiency Syndrome; AIDS; Human Immunodeficiency Virus; HIV Infections

Keywords

Acquired Immune Deficiency Syndrome; AIDS; Anti-Infective Agents; Antiretroviral; Antiviral Agents; Atazanavir; Human Immunodeficiency Virus; HIV; HIV Protease Inhibitors; NRTI; Nucleoside Reverse Transcriptase Inhibitors; Raltegravir; Resistance; treatment experienced

Outcome Measures

Primary Outcomes (1)

• Number of Patients Reaching Virologic Failure at Week 48.

  Virologic failure was defined by protocol as a plasma HIV RNA \>50 c/mL on 2 consecutive occasions \>7 days apart or \> 10 000 c/mL on one occasion (in the absence of an intercurrent infection or recent immunization).

  48 Weeks

Secondary Outcomes (5)

• Number of Patients With < 400 Copies HIV RNA/mL at Week 48

  48 weeks

• CD4+ Cell Count

  Weeks 24

• CD4+ Cell Count

  Week 48

• Cholesterol

  baseline, week 24, week 48

• Mean Change in Total Bilirubin (mg/dL) From Baseline

  baseline and 48 weeks

Study Arms (2)

a.

ACTIVE COMPARATOR

N(t)RTI(s) based backbone \& PI/r

Other: Standard treatment regimen

b.

EXPERIMENTAL

Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID

Drug: Raltegravir; Drug: Atazanavir

Interventions

Raltegravir DRUG

400 mg BID

Also known as: Isentress

b.

Atazanavir DRUG

300 mg BID

Also known as: Reyataz

b.

Standard treatment regimen OTHER

N(t)RTI(s) based backbone plus ritonavir boosted PI

a.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Yale University: lead
• Bristol-Myers Squibb: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (5)

Yale University School of Medicine

New Haven, Connecticut, 06504, United States

Location

Saint Raphael Healthcare System

New Haven, Connecticut, 06511, United States

Location

Waterbury Hospital

Waterbury, Connecticut, 06721, United States

Location

VA CT Healthcare Systems

West Haven, Connecticut, 06516, United States

Location

Comprehensive Care Center, Inc (dba Community AIDS Network)

Sarasota, Florida, 34237, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections

Interventions

Raltegravir Potassium; Atazanavir Sulfate

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridines; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Michael J. Kozal
• Organization: Yale University School of Medicine: Internal Medicine: Infectious Diseases: AIDS Care Program / Viral Hepatitis Program

michael.kozal@yale.edu

(203)737-4040

Study Officials

• Michael J Kozal, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 25, 2008
• Study Start: May 1, 2009
• Primary Completion: May 1, 2013
• Study Completion: November 1, 2013
• Last Updated: February 4, 2016
• Results First Posted: February 4, 2016

Record last verified: 2016-01

Locations

US (5)