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A Treatment Access Program To Provide Maraviroc To Eligible Adult Patients Completing A4001050 Study Until Commercial Availability Of Maraviroc (Celsentri) In India

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ClinicalTrials.gov Identifier: NCT00992654
Expanded Access Status : No longer available
First Posted : October 9, 2009
Last Update Posted : September 27, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare

Brief Summary:
The new protocol will allow the patients enrolled on A4001050 to have continuous access of Maraviroc and the treatment will not be interrupted until the drug is commercially available in India.

Condition or disease Intervention/treatment
Human Immunodeficiency Virus (HIV) Drug: Open Label Treatment Access: Maraviroc

Study Type : Expanded Access
Official Title: A Local, Multicentre, Open Label Access Program To Provide Maraviroc To Eligible Adult Patients Completing A4001050 Study Until Commercial Availability Of Maraviroc (Celsentri) In India

Resource links provided by the National Library of Medicine

Drug Information available for: Maraviroc


Intervention Details:
  • Drug: Open Label Treatment Access: Maraviroc
    Oral dosing twice daily. The dose will depend on the optimized background therapy.
    Other Name: Maraviroc, Celsentri, Selzentry

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who complete the A4001050 study and are continuing to derive benefit from Maraviroc.
  • Subjects who are willing and able to comply with scheduled visits, treatment plan and other study procedures.

Exclusion Criteria:

  • Subjects who discontinued in A4001050 study.
  • Unable to provide consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00992654


Sponsors and Collaborators
ViiV Healthcare
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00992654     History of Changes
Other Study ID Numbers: A4001096
A4001050
First Posted: October 9, 2009    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018

Keywords provided by ViiV Healthcare:
Open Label Access Program
Treatment experienced

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