FindTrial
Sign In

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

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

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT01776996
Enrollment
Unknown
Registered
2013-01-28
Start date
Unknown
Completion date
Unknown
Last updated
2017-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Human Immunodeficiency Virus

Keywords

Expanded access, HIV, maraviroc

Brief summary

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.

Interventions

DRUGContinued 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.

Sponsors

GlaxoSmithKline
CollaboratorINDUSTRY
ViiV Healthcare
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum

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 must agree to use an acceptable method of contraception for the duration of the study as outlined at the end of the inclusion criteria. * 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.

Countries

Argentina, Belgium, Italy, Poland, Russia, South Africa, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026