Phase IIB Pilot of Atazanavir + Raltegravir

NCT00768989 | Terminated Phase 2 Results

• 1 other identifier: AI424-376
• Study Type: interventional
• Target: 167
• Locations: 3 countries
• Sites: 16

Brief Summary

The purpose of this study is to determine if the combination of atazanavir and raltegravir taken together is safe and effective in the treatment of human immunodeficiency virus (HIV).

Conditions

HIV

Keywords

Combination Therapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Level <50 Copies/mL at Week 24

  The number of HIV 1-infected treatment-naive participants with an HIV RNA level \<50 copies/mL after 24 weeks of treatment. Confirmed virologic response noncompleter=failure (NC=F); noncompleter=missing (NC=M); virologic response-observed cases (VR-OC).

  At Week 24 from Baseline

Secondary Outcomes (28)

• Number of Nonresponders at Week 8

  At Week 8 from Baseline

• Number of Participants With HIV RNA Levels <50 Copies/mL at Weeks 48 and 96

  At Weeks 48 and 96 from Baseline

• Number of Participants With HIV RNA Levels <400 Copies/mL at Week 24

  At Week 24 from Baseline

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

  At Week 48 from Baseline

• Number of Participants With HIV RNA Levels <400 Copies/mL at Week 96

  At Week 96 from Baseline

Study Arms (2)

Atazanavir + Raltegravir

EXPERIMENTAL

Atazanavir 300 mg twice daily + Raltegravir 400 mg twice daily

Drug: Atazanavir; Drug: Raltegravir

Atazanavir + Ritonavir + Tenofovir /Emtricitabine

ACTIVE COMPARATOR

Atazanavir, 300 mg once daily, + Ritonavir, 100 mg once daily, + Tenofovir 300 mg/Emtricitabine, 200 mg once daily

Drug: Atazanavir; Drug: Ritonavir; Drug: Tenofovir/Emtricitabine

Interventions

Atazanavir DRUG

Capsules, Oral, 300 mg, twice daily, 96 weeks

Also known as: Reyataz, BMS-232632

Atazanavir + Raltegravir

Raltegravir DRUG

Tablet, Oral, 400 mg, twice daily, 96 weeks

Atazanavir + Raltegravir

Ritonavir DRUG

Capsules, Oral, 100 mg, once daily, 96 weeks

Atazanavir + Ritonavir + Tenofovir /Emtricitabine

Tenofovir/Emtricitabine DRUG

Tablet, Oral, 300-mg Tenofovir/200-mg Emtricitabine, once daily, 96 weeks

Also known as: Truvada

Atazanavir + Ritonavir + Tenofovir /Emtricitabine

Eligibility Criteria

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

You may qualify if:

• Human Immunodeficiency Virus (HIV)-1 positive status
• HIV ribonucleic acid (RNA) level \>=5000 copies/mL
• Antiretroviral treatment-naive
• Absolute Cluster of Differentiation 4 (CD4) cell count meeting 1 of the following criteria:
• \<350 cells/mm\^3
• Screening CD4 \>=350 and \<=500 cells/mm\^3 ONLY if at least 1 of the following conditions apply:
• Screening HIV RNA level \>100,000 copies/mL, or
• CD4 decline \>50-100 cells/mm\^3/year, or
• Age \>=55 years
• Any CD4 cell count, if participant has a history of an acquired immune deficiency syndrome-defining illness
• Medically stable

You may not qualify if:

• Screening HIV genotype showing resistance to any component of the study regimen (Atazanavir, Raltegravir, Tenofovir/Emtricitabine)
• Hepatitis B or hepatitis C coinfection
• History of or current cardiac disease
• Electrocardiogram findings:
• PR Interval \>260 msec (severe 1st degree atrioventricular block)
• QRS Interval \>120 msec

Sponsors & Collaborators

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

Study Sites (16)

Southwest Center For HIV/AIDS

Phoenix, Arizona, 85006, United States

Location

Yale University School Of Medicine

New Haven, Connecticut, 06510, United States

Location

Dupont Circle Physicians Group

Washington D.C., District of Columbia, 20009, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

The Aaron Diamond AIDS Research Center

New York, New York, 10016, United States

Location

University Of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Tarrant County Infectious Disease Associates

Fort Worth, Texas, 76104, United States

Location

Therapeutic Concepts, P.A.

Houston, Texas, 77004, United States

Location

Diversified Medical Practices, P.A.

Houston, Texas, 77057, United States

Location

Local Institution

Buenos Aires, Bs As, Buenos Aires, 1141, Argentina

Location

Local Institution

Capital Federal, Buenos Aires, 1264, Argentina

Location

Local Institution

Mar del Plata, Buenos Aires, B7600CTO, Argentina

Location

Local Institution

Rosario, Santa Fe Province, 2000, Argentina

Location

Local Institution

Nantes, 44035, France

Location

Local Institution

Paris, 75475, France

Location

Local Institution

Paris, 75970, France

Location

Related Publications (1)

• Kozal MJ, Lupo S, DeJesus E, Molina JM, McDonald C, Raffi F, Benetucci J, Mancini M, Yang R, Wirtz V, Percival L, Zhang J, Zhu L, Arikan D, Farajallah A, Nguyen BY, Leavitt R, McGrath D, Lataillade M, The Spartan Study Team. A nucleoside- and ritonavir-sparing regimen containing atazanavir plus raltegravir in antiretroviral treatment-naive HIV-infected patients: SPARTAN study results. HIV Clin Trials. 2012 May-Jun;13(3):119-30. doi: 10.1310/hct1303-119.

  PMID: 22592092 DERIVED

Related Links

• Investigator Inquiry form

MeSH Terms

Interventions

Atazanavir Sulfate; Raltegravir Potassium; Ritonavir; Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Pyrrolidinones; Pyrrolidines; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Organophosphonates; Organophosphorus Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: BMS Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2008
• First Posted: October 8, 2008
• Study Start: November 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: May 1, 2010
• Last Updated: February 24, 2012
• Results First Posted: January 16, 2012

Record last verified: 2012-02

Locations

US (9); FR (3); AR (4)