EuroSIDA As An External Comparator To MOTIVATE Trials

ViiV Healthcare

Status: Completed

Conditions: AIDS; HIV

Treatments: Other: maraviroc

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01329783

A4001104

Details and patient eligibility

About

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.

Full description

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

Enrollment: 1,181 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

None

Trial design

1,181 participants in 1 patient group

EuroSIDA sub-cohort

Description:

HIV infected patients in the EuroSIDA cohort who meet the entry criteria for maraviroc pivotal clinical trials (MOTIVATE 1 and MOTIVATE 2)

Treatment:

Other: maraviroc