At a glance

ClinicalIndex Comparison Record

N/ACompleted· 68 enrolled

Drug / intervention

CELSENTRI® Tabletsdrug

Likely dose

CELSENTRI® Tablets 150mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00864474

NCT00864474N/ACompleted

Compare CT.gov

DRUG USE INVESTIGATION FOR HIV INFECTION PATIENTS OF MARAVIROC (REGULATORY POST MARKETING COMMITMENT PLAN).

ViiV Healthcare·observational·Posted Mar 18, 2009·Updated Jan 2, 2020

In Brief

An observational study evaluating CELSENTRI® Tablets for CCR5-tropic HIV-1 Infection. Completed, enrolled 68 participants.

Detailed Summary

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Study Details

Study Typeobservational

Allocation--

Masking--

Primary Purpose--

ConditionsCCR5-tropic HIV-1 Infection

Countries--

CollaboratorsPfizer

Timeline

N/ACompletedFinished

200920102011201220132014201520162017201820192020202120222023202420252026

First PostedMar 2009

Enrollment StartMar 2010

Primary CompletionDec 2018

TodayJul 2026

First PostedMar 18, 2009

Enrollment StartMar 31, 2010

Primary CompletionDec 24, 2018

TodayJul 2, 2026

Enrollment to primary: 8.7 yearsPosted 17.3 years ago

Interventions

CELSENTRI® Tabletsdrug

CELSENTRI ® Tablets 150mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food".