CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 119 enrolled
Drug / intervention
SCH-D (vicriviroc) +1 moredrug
Likely dose
SCH-D (vicriviroc) 5 mgfrom 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/NCT00082498
NCT00082498Phase 2Completed
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Phase II, Randomized, Double-Blind Study of the Safety and Efficacy of Vicriviroc (An Orally Administered HIV-1 Entry Inhibitor) in HIV-Infected, Treatment-Experienced Subjects

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted May 12, 2004·Updated Nov 1, 2021

In Brief

A Phase 2 clinical trial evaluating SCH-D (vicriviroc) and Placebo for HIV Infections. Completed, enrolled 119 participants across 30 sites.

Detailed Summary

New treatment options are critical for treatment-experienced HIV infected patients with drug resistance. HIV entry inhibitors have been shown effective in patients with resistance to other anti-HIV drugs. This study will test the safety and effectiveness of three different doses of vicriviroc (formerly known as Schering D, SCH-D, or SCH 417690) in HIV infected patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
CollaboratorsAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 12, 2004
Enrollment StartMay 1, 2004
Primary CompletionDec 1, 2005
Study CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 22.1 years ago

Interventions

SCH-D (vicriviroc)drug

Group 2 will receive 5 mg vicriviroc daily; Group 3 will receive 10 mg vicriviroc daily; and Group 4 will receive 15 mg vicriviroc daily. If at or after Week 16 a participant's viral load has not met certain criteria, a dose increase of vicriviroc may occur and the participant will enter Step 2. As of 10/12/05, patients in Group 2 and any patients who entered Step 2 following virologic failure in Step 1 will be unblinded and offered either 15 mg vicriviroc daily through this study or the option of seeking alternative treatment.

Placebodrug

Patients in Group 1 will receive placebo.