EuroSIDA As An External Comparator To MOTIVATE Trials
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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: NCT01329783 |
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Recruitment Status
:
Completed
First Posted
: April 6, 2011
Last Update Posted
: May 16, 2011
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Sponsor:
ViiV Healthcare
Collaborators:
Copenhagen HIV Programme
Pfizer
Information provided by:
ViiV Healthcare
- Study Details
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- No Results Posted
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Brief Summary:
Human Immunodeficiency Virus (HIV) infected patients who meet the entry criteria for the maraviroc pivotal trials (Maraviroc versus Optimized Therapy in Viremic Antiretroviral Treatment-Experienced Patients, MOTIVATE) will be identified from the EuroSIDA HIV cohort. The rates of specific clinical adverse events in this identified patient population will be compared with the rates of these events in the participants of the MOTIVATE trials.
| Condition or disease | Intervention/treatment |
|---|---|
| HIV AIDS | Other: maraviroc |
All patients in EuroSIDA cohort that meet the entry criteria of MOTIVATE trials are included without any sampling.
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Maraviroc
U.S. FDA Resources
| Group/Cohort | Intervention/treatment |
|---|---|
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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)
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Other: maraviroc
No intervention is distributed during this trial.
Other Name: Selzentry, Celsentri
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Primary Outcome Measures
:
- 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 ]
Information from the National Library of Medicine
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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 |
Study Population
- 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
Criteria
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:
Information from the National Library of Medicine
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
Sponsors and Collaborators
ViiV Healthcare
Copenhagen HIV Programme
Pfizer
Investigators
| 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:
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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 |