- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00551018
Efficacy and Safety of VICRIVIROC in HIV-Infected Treatment-Naïve Subjects (Study P04875)
February 5, 2015 updated by: Merck Sharp & Dohme LLC
Efficacy and Safety of VICRIVIROC in HIV-Infected Treatment-Naïve Subjects
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
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; a third interim analysis will be performed when subjects in this second cohort have completed 24 weeks of treatment.
The primary efficacy analysis will be conducted when all 200 subjects from both stages have completed 48 weeks of treatment or discontinued.
The final analysis will be performed at Week 96, when all 200 subjects have completed 96 weeks of treatment or discontinued.
If vicriviroc is shown to provide benefit at the studied dose, study participants in the vicriviroc arm who complete 96 weeks of treatment may continue in a protocol extension, where they will be offered vicriviroc free of charge until the drug is commercially available in their location or until the sponsor terminates the clinical development of vicriviroc.
Study Type
Interventional
Enrollment (Actual)
218
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 (with the exception of prophylaxis to prevent mother-to-child transmission, and in this case, if no antiretroviral resistance is expected to have developed) and none in the 8 weeks preceding randomization.
- A CD4 cell count of at least 100 cells/(cubic mm) at Screening (or as specified by local treatment guidelines).
- HIV ribonucleic acid (RNA) must be at least 2000 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 50,000/microL, hemoglobin at least 8 g/dL, absolute neutrophil count at least 1000/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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Vicriviroc + Reyataz + ritonavir
vicriviroc 30 mg tablet QD + Reyataz® (atazanavir sulfate) 300 mg (1x300 mg capsule or 2x150 mg capsules) QD + Norvir® (ritonavir) 100 mg capsule QD
|
one 30 mg tablet QD
Other Names:
|
ACTIVE_COMPARATOR: Truvada® + Reyataz + ritonavir
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
|
one 200/300 combination tablet QD
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean change from baseline in log10 HIV RNA
Time Frame: Week 48
|
Week 48
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of subjects with plasma HIV RNA <50 copies/mL
Time Frame: Week 48
|
Week 48
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (ACTUAL)
May 1, 2010
Study Completion (ACTUAL)
October 1, 2010
Study Registration Dates
First Submitted
October 29, 2007
First Submitted That Met QC Criteria
October 29, 2007
First Posted (ESTIMATE)
October 30, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
February 6, 2015
Last Update Submitted That Met QC Criteria
February 5, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Tenofovir
- Emtricitabine
Other Study ID Numbers
- P04875
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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