Human Immunodeficiency Virus Type 1
Conditions
Keywords
Maraviroc Compassionate Use
Brief 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.
Detailed description
This study was cancelled prior to enrollment.
Interventions
DRUGMaraviroc
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.
Sponsors
Pfizer
ViiV Healthcare
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety analysis will include all subjects who receive at least one dose of study drug | Two Years |
Secondary
| Measure | Time frame |
|---|---|
| Safety analysis will include all subjects who receive at least one dose of study drug | Two years |
Outcome results
None listed