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NCT00992654 Clinical Trial

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

Human Immunodeficiency Virus (HIV) Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT00992654
Other study ID # A4001096
Secondary ID A4001050
Status No longer available
Phase
First received
Last updated

Study information
Verified date September 2018
Source ViiV Healthcare
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Open Label Treatment Access: Maraviroc
Oral dosing twice daily. The dose will depend on the optimized background therapy.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
ViiV Healthcare Pfizer
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