NCT01428596

Safety and Immunogenicity of HIVAX in HIV-1 Infected Subjects

A Phase I Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of a Replication-defective HIV-1 Vaccine (HIVAX™) in HIV-1 Infected Subjects Receiving Highly Active Antiretroviral Therapy

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: GeneCure Biotechnologies · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study is to test a therapeutic HIV-1 vaccine (HIVAX™) in HIV-1 infected subjects. The safety and immune responses will be studied in vaccine recipients. The anti-viral effect of HIVAX vaccine will be monitored during a 12-week treatment interruption phase.

Detailed description

This is a randomized, placebo-controlled dose-escalation clinical trial to evaluate the safety and the immunogenicity of two doses of a replication defective HIV-1 vaccine (HIVAX™) in subjects receiving stable highly active antiretroviral therapy (HAART) who have an HIV-1 RNA \<50 copies/ml and CD4 cell count \>500 cells/mm3. Following the randomized placebo-controlled vaccination phase subjects who received active vaccine and who meet eligibility will undergo a 12-week analytical antiretroviral treatment interruption followed by reinstitution of antiretroviral therapy (or continued interruption) with follow up through week 48.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	HIVAX	Vaccine 1.0 ml SQ lower dose (10\^8 TU) at weeks 0, 8 and 16.
BIOLOGICAL	saline solution	Saline solution 1.0 ml SQ at weeks 0, 8 and 16.
BIOLOGICAL	HIVAX	Vaccine 1.0 ml SQ higher dose (10\^9 TU) at weeks 0, 8 and 16.

Timeline

• Start date: 2010-09-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2011-09-05
• Last updated: 2020-06-09

Locations

1 site across 1 country: United States