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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01329783
Other study ID # A4001104
Secondary ID
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


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
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