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NCT01776996 Clinical Trial

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

Infection, Human Immunodeficiency Virus Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT01776996
Other study ID # 116278
Secondary ID
Status No longer available
Phase N/A
First received January 24, 2013
Last updated April 4, 2017

Study information
Verified date April 2017
Source ViiV Healthcare
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 16 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Argentina GSK Investigational Site Buenos Aires
Argentina GSK Investigational Site Buenos Aires
Argentina GSK Investigational Site Buenos Aires
Argentina GSK Investigational Site Rosario Santa Fe
Belgium GSK Investigational Site Brussels
Belgium GSK Investigational Site Gent
Belgium GSK Investigational Site Leuven
Italy GSK Investigational Site Milano Lombardia
Italy GSK Investigational Site Modena
Poland GSK Investigational Site Bydgoszcz
Russian Federation GSK Investigational Site Moscow
Russian Federation GSK Investigational Site Moscow
Russian Federation GSK Investigational Site N.Novgorod
Russian Federation GSK Investigational Site Saint-Petersburg
Russian Federation GSK Investigational Site Smolensk
Russian Federation GSK Investigational Site St. Petersburg
South Africa GSK Investigational Site Bloemfontein
South Africa GSK Investigational Site Dundee
South Africa GSK Investigational Site Gauteng
South Africa GSK Investigational Site Port Elizabeth
South Africa GSK Investigational Site Port Elizabeth Eastern Cape
South Africa GSK Investigational Site Pretoria
South Africa GSK Investigational Site Pretoria North
South Africa GSK Investigational Site Soweto Gauteng
South Africa GSK Investigational Site Westdene
Switzerland GSK Investigational Site Bern
Switzerland GSK Investigational Site Lugano
Switzerland GSK Investigational Site Zuerich

Sponsors (2)
Lead Sponsor Collaborator
ViiV Healthcare GlaxoSmithKline

Countries where clinical trial is conducted

Argentina,  Belgium,  Italy,  Poland,  Russian Federation,  South Africa,  Switzerland, 

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