CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 96 enrolled
Drug / intervention
AVX101 +1 morebiological
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/NCT00097838
NCT00097838Phase 1Completed
CompareCT.gov

A Phase I, Dose Escalation, Safety, and Immunogenicity Trial of an Alphavirus Replicon HIV-1 Subtype C Gag Vaccine (AVX101) in Healthy HIV-1 Uninfected Adult Participants

AlphaVax, Inc.·interventional·Posted Dec 1, 2004·Updated Jul 2, 2012

In Brief

A Phase 1 clinical trial evaluating AVX101 and placebo for HIV Infections. Completed, enrolled 96 participants across 8 sites in 3 countries.

Detailed Summary

The purpose of this study is to evaluate the safety of and immune response to an alphavirus replicon, HIV-1 subtype C gag vaccine, AVX101, in HIV uninfected adults in the United States, South Africa, and Botswana.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesBotswana, South Africa, United States
CollaboratorsHIV Vaccine Trials Network, National Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 1, 2004
Enrollment StartOct 1, 2004
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 21.6 years ago

Interventions

AVX101biological

Alphavirus replicon particle vaccine expressing HIV Gag antigen

placeboother

phosphate buffered saline, pH 7.2, HSA, sodium gluconate, and sucrose