EuroSIDA As An External Comparator To MOTIVATE Trials - Full Text View

Purpose

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	Intervention	Phase
HIV AIDS	Other: maraviroc	Phase 4


Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Maraviroc

U.S. FDA Resources

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:

Malignancy [ Time Frame: Median follow up of 3 years ] [ Designated as safety issue: Yes ]
Opportunistic infection [ Time Frame: Median follow up of 3 years ] [ Designated as safety issue: Yes ]
Myocardial infarction [ Time Frame: Median follow up of 3 years ] [ Designated as safety issue: Yes ]
All cause death [ Time Frame: Median follow up of 3 years ] [ Designated as safety issue: Yes ]
Liver related death [ Time Frame: Median follow up of 3 years ] [ Designated as safety issue: Yes ]


Enrollment:	1181
Study Start Date:	April 2007
Study Completion Date:	March 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

Detailed Description:

All patients in EuroSIDA cohort that meet the entry criteria of MOTIVATE trials are included without any sampling.

Eligibility


Ages Eligible for Study:	16 Years and older (Child, Adult, Senior)
Genders Eligible for Study:	Both
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:

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329783

Sponsors and Collaborators

ViiV Healthcare

Copenhagen HIV Programme

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site


Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT01329783 History of Changes
Other Study ID Numbers:	A4001104
Study First Received:	March 16, 2011
Last Updated:	May 13, 2011
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 27, 2016