EuroSIDA As An External Comparator To MOTIVATE Trials
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ClinicalTrials.gov Identifier: NCT01329783 |
Recruitment Status
:
Completed
First Posted
: April 6, 2011
Last Update Posted
: May 16, 2011
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Condition or disease | Intervention/treatment |
---|---|
HIV AIDS | Other: maraviroc |
Study Type : | Observational |
Actual Enrollment : | 1181 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | Incidence And Risk Factors For Acquired Immune Deficiency Syndrome (AIDS) Defining And Non-AIDS Defining Malignancies, And Other AIDS Defining Illnesses In The EuroSIDA Study |
Study Start Date : | April 2007 |
Actual Primary Completion Date : | March 2011 |
Actual Study Completion Date : | March 2011 |

Group/Cohort | Intervention/treatment |
---|---|
EuroSIDA sub-cohort
HIV infected patients in the EuroSIDA cohort who meet the entry criteria for maraviroc pivotal clinical trials (MOTIVATE 1 and MOTIVATE 2)
|
Other: maraviroc
No intervention is distributed during this trial.
Other Name: Selzentry, Celsentri
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- Malignancy [ Time Frame: Median follow up of 3 years ]
- Opportunistic infection [ Time Frame: Median follow up of 3 years ]
- Myocardial infarction [ Time Frame: Median follow up of 3 years ]
- All cause death [ Time Frame: Median follow up of 3 years ]
- Liver related death [ Time Frame: Median follow up of 3 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 |
Sampling Method: | Non-Probability Sample |
- Patient aged over 16 at baseline.
- Viral Load (VL) > 5000 copies/ml at baseline (and measured in 6 months prior to baseline).
- No changes in antiretroviral (ARV) regimens in the month period prior to baseline, or on no ARVs in the month prior to baseline.
- > 3 months exposure (sequential or cumulative) to at least 3 of the following;
- Any nucleoside or nucleotide reverse transcriptase inhibitor (NRTI)
- Non-nucleoside reverse transcriptase inhibitor (NNNRTI)
- Protease Inhibitor (PI )
- Enfuvirtide
Inclusion Criteria:
- Patient aged over 16 at baseline.
- Viral Load (VL) > 5000 copies/ml at baseline (and measured in 6 months prior to baseline).
- No changes in antiretroviral (ARV) regimens in the month period prior to baseline, or on no ARVs in the month prior to baseline.
- > 3 months exposure (sequential or cumulative) to at least 3 of the following;
- Any nucleoside or nucleotide reverse transcriptase inhibitor (NRTI)
- Non-nucleoside reverse transcriptase inhibitor (NNNRTI)
- Protease Inhibitor (PI )
- Enfuvirtide
Exclusion Criteria:

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): NCT01329783
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
ClinicalTrials.gov Identifier: | NCT01329783 History of Changes |
Other Study ID Numbers: |
A4001104 |
First Posted: | April 6, 2011 Key Record Dates |
Last Update Posted: | May 16, 2011 |
Last Verified: | May 2011 |
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Maraviroc CCR5 Receptor Antagonists Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |