Efficacy and Safety of VICRIVIROC in HIV-Infected Treatment-Naïve Subjects (Study P04875AM2) - Full Text View

Sponsors and Collaborators:	Schering-Plough Bristol-Myers Squibb
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00551018

Purpose

Vicriviroc (vye-kri-VYE-rock) is an investigational drug (not yet approved by Government Regulatory Authorities for commercial use) that belongs to a new class of drugs, called CCR5 receptor blockers. This group of drugs blocks one of the ways HIV enters T-cells (the cells that fight infection). Previous smaller studies in HIV treatment-experienced patients, have shown that vicriviroc is safe and effective. The purpose of this study is to evaluate the virologic efficacy of vicriviroc combined with ritonavir-boosted Reyataz® in HIV-infected treatment-naïve subjects.

Condition	Intervention	Phase
HIV Infections	Drug: Vicriviroc Drug: emtricitabine and tenofovir disoproxil fumarate	Phase II Phase III

MedlinePlus related topics: AIDS

Drug Information available for: Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate Truvada Vicriviroc

U.S. FDA Resources

Study Type:

Interventional

Study Design:

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:

Efficacy and Safety of VICRIVIROC in HIV-Infected Treatment-Naïve Subjects

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Mean change from baseline in log10 HIV RNA [ Time Frame: Week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects with plasma HIV RNA <50 copies/mL [ Time Frame: Week 48 ] [ Designated as safety issue: No ]

Estimated Enrollment:

200

Study Start Date:

December 2007

Estimated Study Completion Date:

June 2010

Estimated Primary Completion Date:

June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Vicriviroc + Reyataz + ritonavir: Experimental vicriviroc 30 mg tablet QD + Reyataz® (atazanavir sulfate) 300 mg (1x300 mg capsule or 2x150 mg capsules) QD + Norvir® (ritonavir) 100 mg capsule QD	Drug: Vicriviroc one 30 mg tablet QD
Truvada® + Reyataz + ritonavir: Active Comparator Truvada® 200/300 combination tablet QD + Reyataz® (atazanavir sulfate) 300 mg (1x300 mg capsule or 2x150 mg capsules) QD + Norvir® (ritonavir) 100 mg capsule QD	Drug: emtricitabine and tenofovir disoproxil fumarate one 200/300 combination tablet QD

Detailed Description:

This is a randomized, open-label, active-controlled, parallel-group, multi-center study of vicriviroc maleate in treatment-naïve subjects infected with CCR5-tropic HIV. The study will compare the virologic benefit of vicriviroc combined with ritonavir-boosted Reyataz to a control group receiving Truvada plus ritonavir-boosted Reyataz. Primary efficacy analysis will be conducted when all subjects have completed 48 weeks of treatment. Interim analyses will be performed when the first cohort of 80 subjects have completed 24 weeks and 48 weeks of treatment. The second cohort of 120 subjects will be enrolled after the first interim analysis. If vicriviroc at the dose studied proves to be safe and efficacious, study participants who successfully complete 48 weeks of treatment or for whom vicriviroc is medically appropriate will be offered vicriviroc free of charge until the drug is commercially available.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Adult subjects at least 18 years old or minimum age that defines an adult as determined by local regulatory authorities or legal requirements) of either sex or any race with CCR5-tropic HIV infection.
Cumulative lifetime anti-retroviral therapy exposure of at most 4 weeks and none in the 8 weeks preceding randomization.
A CD4 cell count of at least 200 cells/(cubic mm) at Screening.
HIV ribonucleic acid (RNA) must be at least 5000 copies/mL at Screening.
Subjects should meet International AIDS Society (IAS), Department of Health and Human Services (DHSS), or local recommendations for initiation of antiretroviral therapy (ART).
Platelet count must be at least 75,000/microL, hemoglobin at least 9 g/dL, absolute neutrophil count at least 1500/microL, serum creatinine <2.0 mg/dL (154 micromol/L), and SGOT/SGPT (serum glutamic oxaloacetic transaminase/serum glutamic pyruvic transaminase) at most 3 x upper limit of normal at Screening. Other clinical laboratory tests must be within normal limits or clinically acceptable to the investigator.
Female subjects of childbearing potential must be using a medically accepted method of birth control prior to Screening and agree to continue its use during the study, or must have been surgically sterilized.
Female subjects of childbearing potential must have a negative serum beta-hCG (human chorionic gonadotropin) pregnancy test at Screening and a negative urine beta-hCG pregnancy test on Day 1 prior to dosing.

Exclusion Criteria:

Female subjects of childbearing potential who are breastfeeding, pregnant, or planning to become pregnant.
Subjects with intercurrent illness, vaccinations, or who have used immunomodulators (within the 4 week period prior to randomization) that could influence plasma HIV RNA levels.
CXCR4 or dual-mixed (CXCR4 and CCR5) tropism.
Subjects with primary resistance mutations to any of proposed components of the study arms.
Subjects with active opportunistic infection or malignancy.
Subjects with seizure disorder requiring ongoing anti-seizure therapy or with a history of a seizure disorder who are, in the judgment of the investigator, at risk for seizures.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551018

Contacts

Contact: SP Clinical Trial Registry Call Center

1-888-772-8734

Locations

United States, California
Investigational Site 22	Recruiting
Palm Springs, California, United States, 92262
United States, Florida
Investigational Site 18	Recruiting
Orlando, Florida, United States, 32803
United States, New Jersey
Investigational Site 20	Recruiting
Newark, New Jersey, United States, 07102
United States, New York
Investigational Site 24	Recruiting
Bronx, New York, United States, 10467
United States, Texas
Investigational Site 19	Recruiting
Houston, Texas, United States, 77004
Investigational Site 23	Recruiting
Houston, Texas, United States, 77009
Germany
Investigational Site 7	Recruiting
Koeln, Germany, 50937
Guatemala
Investigational Site 14	Active, not recruiting
Guatemala, Guatemala, 01009
Honduras
Investigational Site 15	Active, not recruiting
San Pedro Sula, Honduras
Italy
Investigational Site 9	Recruiting
Milano, Italy, 20127
Investigational Site 8	Recruiting
Brescia, Italy, 25123
Investigational Site 10	Recruiting
Milano, Italy
Portugal
Investigational Site 13	Recruiting
Porto, Portugal, 4369-004
Investigational Site 12	Recruiting
Lisboa, Portugal, 1649-035
South Africa
Investigational Site 1	Recruiting
Meadowdale, Edenvale G, South Africa, 1610
Investigational Site 2	Recruiting
Johannesburg, South Africa
Investigational Site 3	Recruiting
Westdene, Johannesburg, South Africa, 2042
Investigational Site 4	Recruiting
Observatory, Cape Town, South Africa, 7925
Investigational Site 5	Recruiting
Parow, Cape Town, South Africa, 7505
Spain
Investigational Site 17	Recruiting
Badalona, Spain, 08916
Investigational Site 16	Recruiting
Barcelona, Spain, 08036

Sponsors and Collaborators

Schering-Plough

Bristol-Myers Squibb

Investigators

Study Director:

Michael McCarthy, MD

Schering-Plough

More Information

Responsible Party:

Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )

Study ID Numbers:

P04875

First Received:

October 29, 2007

Last Updated:

December 14, 2008

ClinicalTrials.gov Identifier:

NCT00551018

Health Authority:

United States: Food and Drug Administration

Keywords provided by Schering-Plough:

Treatment Naive

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Emtricitabine
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Tenofovir
Retroviridae Infections
Immunologic Deficiency Syndromes
Tenofovir disoproxil

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection

Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 07, 2009