Maraviroc Compassionate Use

Human Immunodeficiency Virus Type 1 Clinical Trial

Official title:

Maraviroc Compassionate Use

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00719823
• Other study ID #: A4001068
• Status: Withdrawn
• Phase: Phase 3
• First received: July 18, 2008
• Last updated: May 3, 2016
• Start date: August 2008
• Est. completion date: May 2010

Study information

• Verified date: May 2016
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to provide Maraviroc on a compassionate use basis to antiretroviral treatment experienced patients infected with CCR5-tropic HIV-1 with urgent unmet medical needs and who, in the opinion of the physician, require Maraviroc to form a viable regimen.

Description:

This study was cancelled prior to enrollment.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Patients at least 16 years old with prior extensive treatment experience with limited further options in need of maraviroc to constitute an effective HIV-1 treatment regimen.

• Have only CCR5-tropic HIV-1 virus

• CD4+ cell count < 200 cells/mm3

Exclusion Criteria:

• CXCR4- or dual/mixed-tropic HIV-1 virus

• Patients who in the opinion of investigator are unlikely to derive benefit from maraviroc as a result of severity of illness

• Patients who are pregnant or breast feeding an infant or planning to become pregnant.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus Type 1
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Maraviroc
Maraviroc 150mg, 300 mg or 600 mg twice daily administered orally with or without food in combination with other antiretroviral agents. The recommended dose of Maraviroc differs based on concomitant medications due to drug interactions as outlined in the Prescribing Information.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety analysis will include all subjects who receive at least one dose of study drug		Two Years	Yes
Secondary	Safety analysis will include all subjects who receive at least one dose of study drug		Two years	No

External Links

•   To obtain contact information for a study center near you, click here.