An Expanded Access Protocol for Subjects Who Have Completed Clinical Studies Involving Maraviroc

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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This is an open-label protocol designed to provide continued access to maraviroc to only those subjects who have completed previous studies of maraviroc and continue to receive clinical benefit.

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Detailed Description

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Conditions

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Infection, Human Immunodeficiency Virus

Interventions

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Continued Access Arm

All subjects will be on maraviroc 300 mg twice a day, unless a dose adjustment is required due to certain concomitant medications. For those subjects in South Africa and Argentina who were previously receiving Combivir along with maraviroc in Study A4001026, Combivir will be supplied as tablets containing 150 mg lamivudine and 300 mg zidovudine. One Combivir tablet will be taken orally twice a day.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
* Subject has participated in a clinical trial that evaluated maraviroc and is continuing to derive clinical benefit from maraviroc treatment.
* Subject agrees to the specified study procedures.

Exclusion Criteria

* Subject who is an investigational site staff member or an employee of the Sponsor that is directly involved in the conduct of the trial.
* Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
* Contra-indications to use of maraviroc as described in the Investigator Brochure.
* Past documented dual/mixed or C-X-C chemokine receptor type 4 HIV tropism.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No