CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 52 enrolled
Drug / intervention
Remune and ALVACbiological
Likely dose
Remune 1 ml intramuscularly at weeks 0, 12, and 20; ALVAC 1 ml intramuscularly at weeks 8, 12, 16, and 20AI-extracted
Key inclusion· 8
  • ✓Documented HIV infection by serology
  • ✓HIV RNA <50 copies/ml for at least 2 years
  • ✓Currently receiving ≥2 antiretroviral agents including ≥1 protease inhibitor or ≥1 NNRTI
  • ✓CD4 count >500 cells/μl
Key exclusion· 7
  • ✕Hepatitis B surface antigen positive
  • ✕Hepatitis C antibody positive
  • ✕AST, ALT, ALP, creatinine, or urea >3× upper limit of normal
  • ✕Hemoglobin <100 g/L, WBC <1500/μl, or platelets <100×10⁹/L

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

Search/NCT00212888
NCT00212888Phase 2Completed
CompareCT.gov

A Pilot Study to Determine the Impact of Therapeutic HIV Vaccination Followed by a Scheduled Interruption of Antiretroviral Therapy on HIV-Specific Immune Function and Virologic Rebound in Patients With Prolonged Viral Suppression

Ottawa Hospital Research Institute·interventional·Posted Sep 21, 2005·Updated Jun 17, 2019

In Brief

A Phase 2 clinical trial evaluating Remune and ALVAC for HIV Infections. Completed, enrolled 52 participants across 3 sites.

Detailed Summary

The purpose of this study is to determine if vaccination before a structured treatment interruption (STI) is associated with an improvement in immune function, resulting in a delayed and reduced rebound in the amount of HIV virus in the blood.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesCanada
CollaboratorsCanadian Institutes of Health Research (CIHR), Ontario HIV Treatment Network, CIHR Canadian HIV Trials Network

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 21, 2005
Enrollment StartApr 1, 2004
Primary CompletionJul 1, 2010
Study CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 20.8 years ago

Interventions

Remune and ALVACbiological

* Group 1) Remune™ (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20); * Group 2) Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20; or * Group 3) Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC placebo (1 ml i.m.) at weeks 8, 12, 16 and 20.