Who is sponsoring ISSP-001?

ISSP-001 is sponsored by Istituto Superiore di Sanità.

What condition does ISSP-001 study?

ISSP-001 studies HIV Infections.

What drugs are being tested in ISSP-001?

Interventions: Biologically active recombinant Tat protein.

What is the status of ISSP-001?

ISSP-001 is currently COMPLETED.

Last reviewed 2011-02-28 · How we verify

A Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat Protein in HIV-1 Uninfected Adult Volunteers (ISSP-001)

NCT00529698 Phase 1 COMPLETED

This Phase I study is directed at evaluating the safety profile (as a primary end-point) and the immunogenicity (as a secondary end-point) of the recombinant HIV-1 Tat vaccine in healthy, immunologically competent adult subjects without identifiable risk of HIV-1 infection.

Details

Lead sponsor	Istituto Superiore di Sanità
Phase	Phase 1
Status	COMPLETED
Enrolment	20
Start date	2004-01
Completion	2007-11

Conditions

HIV Infections

Interventions

Biologically active recombinant Tat protein

Primary outcomes

Assessment of safety includes clinical observation and monitoring of haematological, biochemical, virological and immunological parameters. Safety is evaluated by monitoring of volunteers for local and systemic adverse reactions during the trial.

Countries

Italy