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

DesconocidoClinicalTrials.gov

ID: NCT01776996Tipo: EXPANDED_ACCESS

Enfermedades Infecciosas Alergia e Inmunología

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 16 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

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.

Ubicaciones

GSK Investigational Site

Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

Rosario, Santa Fe Province, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

Patrocinadores

PrincipalViiV Healthcare

ColaboradorGlaxoSmithKline

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