A Pilot Study Of A Novel Treatment Regimen, Maraviroc + Ritonavir Boosted Atazanavir, In Treatment Naive HIV-Infected Patients

NCT00827112 | Completed Phase 2 Results DMC

• 1 other identifier: A4001078
• Study Type: interventional
• Target: 129
• Locations: 3 countries
• Sites: 39

Brief Summary

This is a pilot study to examine if the novel treatment regimen maraviroc plus boosted atazanavir can be expected to be safe and efficacious in treatment naive HIV infected patients. Based on the results from this study, a confirmatory phase 3 study may be conducted.

Conditions

Human Immunodeficiency Virus-1

Keywords

CCR5-tropic HIV-1 virus

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than 50 Copies/Milliliter (mL)

  Week 48

Secondary Outcomes (15)

• HIV-1 RNA Levels at Baseline

  Baseline

• Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14

  Baseline , Days 4, 7, 10 and 14

• Maximum Observed Plasma Concentration (Cmax) of Maraviroc

  Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)

• Minimum Observed Plasma Concentration (Cmin) of Maraviroc

  Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)

• Average Observed Plasma Concentration (Cavg) of Maraviroc

  Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)

Study Arms (2)

Arm A

EXPERIMENTAL

maraviroc (Selzentry, Celsentri) 150 mg QD + atazanavir (Reyataz) /ritonavir (Norvir) 300/100mg QD Subjects experiencing unconjugated hyperbilirubinemia attributable to atazanavir (Reyataz) /ritonavir (Norvir) without any other etiology of hyperbilirubinemia, responding to the therapy without virologic failure, but expressing cosmetic concerns because of the jaundice or scleral icterus (associated with bilirubin elevations) and wish to discontinue atazanavir (Reyataz) in spite of reassurances by the investigator, will be permitted on a single occasion only to switch to another protease inhibitor either darunavir (Prezista)/ritonavir (Norvir)((800/100 mg) QD or lopinavir/ritonavir (Kaletra, Aluvia)(400/100mg) BID and remain in the study. If the investigator decides to switch to a protease inhibitor other than darunavir (Prezista)/ritonavir (Norvir) or lopinavir/ritonavir (Kaletra, Aluvia)(, then the subject must be discontinued from the study.

Drug: maraviroc

Arm B

EXPERIMENTAL

emtricitabine/tenofovir (Truvada) 200/300mg QD + atazanavir (Reyataz) /ritonavir (Norvir) 300/100 mg QD Subjects experiencing unconjugated hyperbilirubinemia attributable to atazanavir (Reyataz) /ritonavir (Norvir) without any other etiology of hyperbilirubinemia, responding to the therapy without virologic failure, but expressing cosmetic concerns because of the jaundice or scleral icterus (associated with bilirubin elevations) and wish to discontinue atazanavir in spite of reassurances by the investigator, will be permitted on a single occasion only to switch to another protease inhibitor either darunavir/ritonavir (800/100 mg) QD or lopinavir/ritonavir (400/100mg) BID and remain in the study. If the investigator decides to switch to a protease inhibitor other than darunavir/ritonavir or lopinavir/ritonavir, then the subject must be discontinued from the study.

Drug: maraviroc

Interventions

maraviroc DRUG

maraviroc (Selzentry, Celsentri) 150mg QD + atazanavir (Reyataz) /ritonavir (Norvir) (300/100mg) QD OR maraviroc (Selzentry, Celsentri) 150mg QD+ darunavir (Prezista)/ritonavir (Norvir) (800/100 mg) QD (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by darunavir (Prezista)/ritonavir (Norvir)) OR maraviroc (Selzentry, Celsentri) 150mg QD+ lopinavir/ritonavir (Kaletra, Aluvia) (400/100 mg) BID (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by lopinavir/ritonavir (Kaletra, Aluvia))

Also known as: maraviroc =Celsentri, Selzentry; atazanavir =Reyataz; ritonavir =Norvir; lopinavir/ritonavir=Kaletra, Aluvia; darunavir=Prezista

Arm A

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-1 RNA viral load of ≥1,000 copies/mL measured at the Screening Visit.
• CD4 count ≥100 cells/mm3 at Screening.
• Have only R5 HIV-1 at Screening as verified by the Monogram Bioscience Trofile® assay with enhanced sensitivity.

You may not qualify if:

• Prior treatment with any other HIV antiretroviral therapy for more than 14 days at any time.
• Any evidence of resistance to atazanavir, tenofovir, and emtricitabine.
• X4-or dual/mixed-tropic virus by enhanced Trofile assay or repeated assay failure or not reportable results.

Sponsors & Collaborators

• ViiV Healthcare: lead
• Pfizer: collaborator

Study Sites (39)

Pfizer Investigational Site

Los Angeles, California, 90027, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90028, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90048, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90069, United States

Location

Pfizer Investigational Site

Norwalk, Connecticut, 06851, United States

Location

Pfizer Investigational Site

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

Location

Pfizer Investigational Site

Miami, Florida, 33133, United States

Location

Pfizer Investigational Site

Miami, Florida, 33136, United States

Location

Pfizer Investigational Site

Miami, Florida, 33137, United States

Location

Pfizer Investigational Site

Orlando, Florida, 32803, United States

Location

Pfizer Investigational Site

Pensacola, Florida, 32504, United States

Location

Pfizer Investigational Site

St. Petersburg, Florida, 33713, United States

Location

Pfizer Investigational Site

Tampa, Florida, 33602, United States

Location

Pfizer Investigational Site

Tampa, Florida, 33614, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30312, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60657, United States

Location

Pfizer Investigational Site

Springfield, Massachusetts, 01107, United States

Location

Pfizer Investigational Site

Springfield, Massachusetts, 01199, United States

Location

Pfizer Investigational Site

Ann Arbor, Michigan, 48109, United States

Location

Pfizer Investigational Site

Omaha, Nebraska, 68106, United States

Location

Pfizer Investigational Site

New York, New York, 10003, United States

Location

Pfizer Investigational Site

Huntersville, North Carolina, 28078, United States

Location

Pfizer Investigational Site

Addison, Texas, 75001, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75204, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75390, United States

Location

Pfizer Investigational Site

Houston, Texas, 77098, United States

Location

Pfizer Investigational Site

Spokane, Washington, 99204, United States

Location

Pfizer Investigational Site

Berlin, 10243, Germany

Location

Pfizer Investigational Site

Berlin, 12157, Germany

Location

Pfizer Investigational Site

Cologne, 50937, Germany

Location

Pfizer Investigational Site

Frankfurt am Main, 60590, Germany

Location

Pfizer Investigational Site

Hamburg, 20146, Germany

Location

Pfizer Investigational Site

München, 80335, Germany

Location

Pfizer Investigational Site

Alicante, Alicante, 03010, Spain

Location

Pfizer Investigational Site

Barcelona, Barcelona, 08036, Spain

Location

Pfizer Investigational Site

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Pfizer Investigational Site

Córdoba, Cordoba, 14004, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, 28046, Spain

Location

Pfizer Investigational Site

Seville, Sevilla, 41013, Spain

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Maraviroc; Lopinavir; lopinavir-ritonavir drug combination; Emtricitabine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidinones; Pyrimidines; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  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: January 21, 2009
• First Posted: January 22, 2009
• Study Start: March 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2011
• Last Updated: June 15, 2012
• Results First Posted: November 24, 2011

Record last verified: 2012-06

Locations

DE (6); ES (6); US (27)