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

Primary Purpose

Infection, Human Immunodeficiency Virus

Status
No longer available
Phase
Locations
International
Study Type
Expanded Access
Intervention
Continued Access Arm
Sponsored by
ViiV Healthcare
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Infection, Human Immunodeficiency Virus focused on measuring Expanded access, HIV, maraviroc

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All Sexes

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 24, 2013
Last Updated
April 4, 2017
Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01776996
Brief Title
An Expanded Access Protocol for Subjects Who Have Completed Clinical Studies Involving Maraviroc
Official Title
An Expanded Access Protocol for Subjects Who Have Completed Clinical Studies Involving Maraviroc
Study Type
Expanded Access

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Human Immunodeficiency Virus
Keywords
Expanded access, HIV, maraviroc

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Continued Access Arm
Intervention Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
ViiV Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
GSK Investigational Site
City
Buenos Aires
ZIP/Postal Code
1202
Country
Argentina
Facility Name
GSK Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1264AAV
Country
Argentina
Facility Name
GSK Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1282AEN
Country
Argentina
Facility Name
GSK Investigational Site
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
GSK Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
GSK Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20127
Country
Italy
Facility Name
GSK Investigational Site
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
GSK Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-030
Country
Poland
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
105275
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
Facility Name
GSK Investigational Site
City
N.Novgorod
ZIP/Postal Code
603005
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
190103
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Smolensk
ZIP/Postal Code
214006
Country
Russian Federation
Facility Name
GSK Investigational Site
City
St. Petersburg
ZIP/Postal Code
196645
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Port Elizabeth
State/Province
Eastern Cape
ZIP/Postal Code
6001
Country
South Africa
Facility Name
GSK Investigational Site
City
Soweto
State/Province
Gauteng
ZIP/Postal Code
2013
Country
South Africa
Facility Name
GSK Investigational Site
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
GSK Investigational Site
City
Dundee
ZIP/Postal Code
3000
Country
South Africa
Facility Name
GSK Investigational Site
City
Gauteng
ZIP/Postal Code
2047
Country
South Africa
Facility Name
GSK Investigational Site
City
Port Elizabeth
ZIP/Postal Code
6070
Country
South Africa
Facility Name
GSK Investigational Site
City
Pretoria North
ZIP/Postal Code
0116
Country
South Africa
Facility Name
GSK Investigational Site
City
Pretoria
ZIP/Postal Code
0083
Country
South Africa
Facility Name
GSK Investigational Site
City
Westdene
ZIP/Postal Code
2092
Country
South Africa
Facility Name
GSK Investigational Site
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
GSK Investigational Site
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Facility Name
GSK Investigational Site
City
Zuerich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

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

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