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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
218

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Drug: Vicriviroc
one 30 mg tablet QD
Other Names:
  • SCH 417690; VCV
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
Drug: emtricitabine and tenofovir disoproxil fumarate
one 200/300 combination tablet QD
Other Names:
  • Truvada®, a combination of Emtriva® (emtricitabine 200 mg) and Viread® (tenofovir disoproxil fumarate 300 mg); emtricitabine + tenofovir DF; FTC + TDF

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Mean change from baseline in log10 HIV RNA
Time Frame: Week 48
Week 48

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck Sharp & Dohme LLC

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2007

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2010

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2007

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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