An Expanded Access Protocol for Subjects Who Have Completed Clinical Studies Involving Maraviroc - Full Text View

Purpose

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.

Condition	Intervention	Phase
Infection, Human Immunodeficiency Virus	Drug: Continued Access Arm	Phase 4


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Expanded Access Protocol for Subjects Who Have Completed Clinical Studies Involving Maraviroc

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Maraviroc

U.S. FDA Resources

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:

Provide continued access to Maraviroc to subjects who have completed previous studies of Maraviroc and continue to receive clinical benefit. [ Time Frame: 2 years ] [ Designated as safety issue: No ]


Enrollment:	120
Study Start Date:	May 2012
Study Completion Date:	August 2016
Primary Completion Date:	August 2016 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Eligibility


Ages Eligible for Study:	16 Years and older (Child, Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01776996

Locations


Argentina
GSK Investigational Site
Rosario, Santa Fe, Argentina, 2000
GSK Investigational Site
Buenos Aires, Argentina, 1202
GSK Investigational Site
Buenos Aires, Argentina, C1264AAV
GSK Investigational Site
Buenos Aires, Argentina, C1282AEN
Belgium
GSK Investigational Site
Brussels, Belgium, 1000
GSK Investigational Site
Gent, Belgium, 9000
GSK Investigational Site
Leuven, Belgium, 3000
Italy
GSK Investigational Site
Milano, Lombardia, Italy, 20127
GSK Investigational Site
Modena, Italy, 41124
Poland
GSK Investigational Site
Bydgoszcz, Poland, 85-030
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 105275
GSK Investigational Site
Moscow, Russian Federation, 129110
GSK Investigational Site
N.Novgorod, Russian Federation, 603005
GSK Investigational Site
Saint-Petersburg, Russian Federation, 190103
GSK Investigational Site
Smolensk, Russian Federation, 214006
GSK Investigational Site
St. Petersburg, Russian Federation, 196645
South Africa
GSK Investigational Site
Port Elizabeth, Eastern Cape, South Africa, 6001
GSK Investigational Site
Soweto, Gauteng, South Africa, 2013
GSK Investigational Site
Bloemfontein, South Africa, 9301
GSK Investigational Site
Dundee, South Africa, 3000
GSK Investigational Site
Gauteng, South Africa, 2047
GSK Investigational Site
Port Elizabeth, South Africa, 6070
GSK Investigational Site
Pretoria North, South Africa, 0116
GSK Investigational Site
Pretoria, South Africa, 0083
GSK Investigational Site
Westdene, South Africa, 2092
Switzerland
GSK Investigational Site
Bern, Switzerland, CH-3010
GSK Investigational Site
Lugano, Switzerland, 6900
GSK Investigational Site
Zuerich, Switzerland, 8091

Sponsors and Collaborators

ViiV Healthcare

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	ViiV Healthcare

More Information


Responsible Party:	ViiV Healthcare
ClinicalTrials.gov Identifier:	NCT01776996 History of Changes
Other Study ID Numbers:	116278
Study First Received:	January 24, 2013
Last Updated:	September 8, 2016
Health Authority:	Argentina: Ciudad Autonma de Buenos Aires

Keywords provided by ViiV Healthcare:


Expanded access, HIV, maraviroc

Additional relevant MeSH terms:


Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral	Sexually Transmitted Diseases Slow Virus Diseases Maraviroc CCR5 Receptor Antagonists Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents

ClinicalTrials.gov processed this record on September 23, 2016