A Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat in HIV-1 Infected Adult Volunteers (ISST-001)

NCT00505401 Phase 1 COMPLETED

The development of a vaccine against HIV/AIDS has been primary focused on the structural proteins (Env, Gag) of HIV-1 with the aim of inducing sterilizing immunity by blocking virus entry. Alternative approaches are focused on new vaccine strategies aimed at modifying the virus-host dynamic favouring the establishment of a long-term non-progressing disease status. Such strategies target regulatory proteins that are the first to be expressed after infection and are essential for viral replication, infectivity and pathogenesis. Thus, this approach may be effective for both preventive and therapeutic vaccination strategies.

Details

Lead sponsor	Istituto Superiore di Sanità
Phase	Phase 1
Status	COMPLETED
Enrolment	27
Start date	2003-12
Completion	2007-11

Conditions

• HIV Infections

Interventions

• recombinant HIV-1 Tat protein

Primary outcomes

• Assessment of product safety included clinical monitoring of volunteers for local and systemic adverse reactions during the course of the trial and monitoring of haematological, biochemical, virological and immunological parameters

Countries

Italy