CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 9 enrolled
Drug / intervention
Vicrivirocdrug
Likely dose
Not stated in 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/NCT00766597
NCT00766597Phase 2Completed

Phase I/II Open-Label Study to Evaluate the PK, Safety, Tolerability and Antiviral Activity of Vicriviroc, a Novel CCR5 Antagonist in Combination Regimens in HIV-Infected ART Experienced Children and Adolescents

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Oct 6, 2008·Updated Nov 5, 2021

In Brief

A Phase 2 clinical trial evaluating Vicriviroc for HIV Infections. Completed, enrolled 9 participants across 9 sites in 2 countries.

Detailed Summary

Complications with current HIV antiretroviral therapy have left many children and adolescents with limited therapeutic options due to drug resistance. The purpose of this study is to test the effectiveness and safety of Vicriviroc (VCV), an HIV entry inhibitor and CCR5 co-receptor antagonist.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesPuerto Rico, United States

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 6, 2008
Enrollment StartAug 1, 2009
Primary CompletionJul 1, 2010
Study CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 17.7 years ago

Interventions

Vicrivirocdrug

Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen