EuroSIDA As An External Comparator To MOTIVATE Trials

HIV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01329783
• Other study ID #: A4001104
• Status: Completed
• Phase: Phase 4
• First received: March 16, 2011
• Last updated: May 13, 2011
• Start date: April 2007
• Est. completion date: March 2011

Study information

• Verified date: May 2011
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1181
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• AIDS
• HIV
• HIV Infections

Intervention

Other:
• maraviroc
No intervention is distributed during this trial.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
ViiV Healthcare	Copenhagen HIV Programme, Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Malignancy		Median follow up of 3 years	Yes
Primary	Opportunistic infection		Median follow up of 3 years	Yes
Primary	Myocardial infarction		Median follow up of 3 years	Yes
Primary	All cause death		Median follow up of 3 years	Yes
Primary	Liver related death		Median follow up of 3 years	Yes

External Links

•   To obtain contact information for a study center near you, click here.