Who is sponsoring NCT00000948?

NCT00000948 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What condition does NCT00000948 study?

NCT00000948 studies HIV Infections.

What drugs are being tested in NCT00000948?

Interventions: Aldesleukin, ART.

What is the status of NCT00000948?

NCT00000948 is currently COMPLETED.

Last reviewed 2021-10-27 · How we verify

A Randomized, Open Label Phase II Study of Subcutaneous Interleukin-2 (Proleukin) Plus Antiretroviral Therapy vs. Antiretroviral Therapy Alone in Patients With HIV Infection and at Least 350 CD4+ Cells/mm3

NCT00000948 Phase 2 COMPLETED

The purpose of this study is to evaluate the safety and tolerability of giving IL-2 plus anti-HIV (antiretroviral) therapy to HIV-positive patients with CD4 cell counts (cells of the immune system that fight infection) of at least 350 cells/mm3. This study will also examine the ability of antiretroviral therapy combined with IL-2 to boost the immune system. IL-2, given through injection under the skin, in combination with anti-HIV therapy can increase CD4 cell counts. This study examines 3 doses of IL-2 in order to determine the safest and most effective dose to use.

Details

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 2
Status	COMPLETED
Enrolment	72
Start date	1998-02

Conditions

HIV Infections

Interventions

Aldesleukin
ART

Primary outcomes

CD4 count — Throughout study
Laboratory and clinical adverse events — Throughout study

Countries

Thailand