Multicenter, Safety Study Of Maraviroc

September 1, 2011 updated by: ViiV Healthcare

A Multicenter, Open Label, Non-Comparative Safety Study Of Maraviroc

To collect safety and tolerability data in a more diverse patient population of patients with HIV/Aids, who have limited therapeutic options.

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.

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.
209

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 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • BA
      • Salvador, BA, Brazil, 40110-160
        • Pfizer Investigational Site
    • DF
      • Brasilia, DF, Brazil, 70351-580
        • Pfizer Investigational Site
    • MG
      • Belo Horizonte, MG, Brazil, 30130-100
        • Pfizer Investigational Site
    • PR
      • Curitiba, PR, Brazil, 80240-280
        • Pfizer Investigational Site
    • RJ
      • Nova Iguaçu, RJ, Brazil, 26030-380
        • Pfizer Investigational Site
    • RS
      • Porto Alegre, RS, Brazil, 90110-270
        • Pfizer Investigational Site
    • SC
      • Florianopolis, SC, Brazil, 88025-301
        • Pfizer Investigational Site
    • SP
      • Campinas, SP, Brazil, 13059-900
        • Pfizer Investigational Site
      • Campinas, SP, Brazil, 13083-887
        • Pfizer Investigational Site
      • Ribeirao Preto, SP, Brazil, 14048900
        • Pfizer Investigational Site
      • Santo Andre, SP, Brazil, 09060-650
        • Pfizer Investigational Site
      • Sao Paulo, SP, Brazil, 01246-900
        • Pfizer Investigational Site
      • Sao Paulo, SP, Brazil, 01307-001
        • Pfizer Investigational Site
      • Sao Paulo, SP, Brazil, 04040-002
        • Pfizer Investigational Site
      • Sao Paulo, SP, Brazil, 04121-000
        • Pfizer Investigational Site
      • São Paulo, SP, Brazil, 04231-030
        • Pfizer Investigational Site

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:

  • Subjects with limited or no approved treatment options available to them due to resistance or intolerance;
  • Subjects must be failing to achieve adequate virologic suppression on their current regimen and have HIV-1 RNA ≥ 1000 copies/ml, at screening.
  • Have only R5 HIV-1 at Screening as verified by the Monogram Biosciences Trofile assay.

Exclusion Criteria:

  • Failed prior treatment with any CCR5 antagonist, in any ongoing CCR5 trials or having previously discontinued Maraviroc in trials
  • Potentially life threatening (Grade 4) laboratory abnormality or medical condition (according to the Division of AIDS table for grading severity of adult adverse experiences) still under investigation unless a diagnosis has been established and felt not to affect risk/benefit assessment or eventual interpretation of safety results, based on discussion between the investigator and Pfizer.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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: 1
Drug: Maraviroc
Maraviroc should be dosed BID with total dose adjusted according to the other drugs the patient is taking. Maraviroc may be taken with or without food. The subject should only take missed doses if it is not within 6 hours prior to the planned next dose. No dose adjustment of OBT is required due to the presence of maraviroc.

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
Measure Description
Time Frame
Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline to 30 days post-week 96 or early termination (ET)
AEs: any untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was congenital anomaly. Grade 3: Events that interrupted participant's usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4: Events which were unacceptable and intolerable or which were irreversible or caused participant to be in imminent danger of death.
Baseline to 30 days post-week 96 or early termination (ET)
Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities
Time Frame: Baseline to 30 days post-week 96 or ET
Grade 3 or severe events included those that interrupted participant's usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4 or very severe events included those that were unacceptable and intolerable or which were irreversible or caused the participant to be in imminent danger of death.
Baseline to 30 days post-week 96 or ET
Number of Participants With Treatment Emergent Malignancies
Time Frame: Baseline to 30 days post-week 96 or ET
Baseline to 30 days post-week 96 or ET
Number of Participants With Category C Acquired Immunodeficiency Syndrome (AIDS) Related Infections
Time Frame: Baseline to 30 days post-week 96 or ET
Number of participants with AIDS-related infections based on investigator classification guided by a predefined list of clinical Category C AEs per Center for Disease Control (CDC) HIV Classification System.
Baseline to 30 days post-week 96 or ET
Number of Participants With Laboratory Test Abnormalities
Time Frame: Baseline to 30 days post-week 96 or ET
Pre-defined criteria based on upper limit normal (ULN) and lower limit normal (LLN) were established for each laboratory test to define the values that would be identified as laboratory test abnormality.
Baseline to 30 days post-week 96 or ET

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
Measure Description
Time Frame
Percentage of Participants With at Least 0.5 Log 10 Reduction in Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA)
Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or end of treatment (EOT)
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or end of treatment (EOT)
Percentage of Participants With at Least 1.0 Log 10 Reduction in HIV-1 RNA
Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Percentage of Participants Achieving HIV-1 RNA Below Limit of Quantification
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Below limit of quantification was defined as less than 400 copies/milliliter (mL)
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Change From Baseline in Lymphocyte Cluster of Differentiation 4 (CD4) Count at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Change From Baseline in Lymphocyte Cluster of Differentiation 8 (CD8) Count at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Change From Baseline in CD4 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Change From Baseline in CD8 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Number of Participants With C-X-C Chemokine Receptor Type 4 {CXCR4} [X4] Tropism Status
Time Frame: Time of virologic failure (VF) and Week 96 or EOT
Virus tropism was done by the Monogram Biosciences Trofile assay.
Time of virologic failure (VF) and Week 96 or EOT

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Human Immunodeficiency Virus (HIV) -1 Viral Load (Ribonucleic Acid [RNA]) at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log 10 copies per milliliter [log10 copies/ml]).
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Time to Virologic Failure (VF)
Time Frame: Baseline to Week 96 or EOT
Virologic failure was defined as failing to achieve a reduction in HIV-1 RNA of at least 0.5 log10 copies/ml from baseline by the second viral load determination; or experiencing at least 0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from baseline more than 0.5 log10 copies/ml; or experiencing an HIV-1 RNA more than 1000 copies/ml after having achieved an HIV-1 RNA below level of quantification.
Baseline to Week 96 or EOT
Number of Participants With Genotype Resistance
Time Frame: Baseline through Week 96
Evolution in resistance to OBT was shown by emergence of new primary or secondary resistance mutations to nucleoside reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI) and protease inhibitor (PI).
Baseline through Week 96

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.
ViiV Healthcare

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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.
July 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.
August 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.
September 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).
May 22, 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.
May 22, 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.
May 24, 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.
September 9, 2011

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.
September 1, 2011

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.
September 1, 2011

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.
  • A4001063

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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