CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
PRO 140 +2 moredrug
Likely dose
PRO 140 10 mg/kgfrom 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/NCT00613379
NCT00613379Phase 2Completed
CompareCT.gov

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of PRO 140 by Intravenous Administration in Adult Subjects With Human Immunodeficiency Virus Type 1 Infection

CytoDyn, Inc.·interventional·Posted Feb 13, 2008·Updated Jul 15, 2016

In Brief

A Phase 2 clinical trial evaluating PRO 140 and Placebo for HIV Infections. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The purpose of this study is: 1. To assess and characterize the PK and PD of PRO 140 administered IV 2. To assess the antiviral activity of PRO 140 3. To assess the safety and tolerability of PRO 140

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 13, 2008
Enrollment StartDec 1, 2007
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.4 years ago

Interventions

PRO 140drug

10 mg/kg PRO 140, one IV dose (N=10)

PRO 140drug

5 mg/kg PRO 140, one IV dose (N=10)

Placebodrug

PBO, one IV dose (N=10)