Maraviroc Compassionate Use
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00719823 |
Recruitment Status
:
Withdrawn
First Posted
: July 22, 2008
Last Update Posted
: May 4, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Human Immunodeficiency Virus Type 1 | Drug: Maraviroc | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Maraviroc Compassionate Use |
Study Start Date : | August 2008 |
Estimated Primary Completion Date : | May 2010 |
Estimated Study Completion Date : | May 2010 |

Arm | Intervention/treatment |
---|---|
1 |
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.
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- Safety analysis will include all subjects who receive at least one dose of study drug [ Time Frame: Two Years ]
- Safety analysis will include all subjects who receive at least one dose of study drug [ Time Frame: Two years ]

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts 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.

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): NCT00719823
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Responsible Party: | ViiV Healthcare |
ClinicalTrials.gov Identifier: | NCT00719823 History of Changes |
Other Study ID Numbers: |
A4001068 |
First Posted: | July 22, 2008 Key Record Dates |
Last Update Posted: | May 4, 2016 |
Last Verified: | May 2016 |
Keywords provided by ViiV Healthcare:
Maraviroc Compassionate Use |
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes 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 |