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

Expanded access is no longer available for this treatment.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01776996
First received: January 24, 2013
Last updated: April 4, 2017
Last verified: April 2017
January 24, 2013
April 4, 2017
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Provide continued access to Maraviroc to subjects who have completed previous studies of Maraviroc and continue to receive clinical benefit. [ Time Frame: 2 years ]
Complete list of historical versions of study NCT01776996 on ClinicalTrials.gov Archive Site
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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
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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Expanded Access:   Available for Intermediate-size Population
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Infection, Human Immunodeficiency Virus
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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
No longer available
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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 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.
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
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Contact information is only displayed when the study is recruiting subjects
Argentina,   Belgium,   Italy,   Poland,   Russian Federation,   South Africa,   Switzerland
 
 
NCT01776996
116278
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ViiV Healthcare
ViiV Healthcare
GlaxoSmithKline
Study Director: GSK Clinical Trials ViiV Healthcare
ViiV Healthcare
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP