drugset / Trial / NCT00000896

A Study to Compare the Effectiveness of a Four Drug Anti-HIV Regimen Given Alone or in Combination With GM-CSF or IL-12 to HIV-Positive Patients

NCT00000896

Open-labelTreatment

Summary

The purpose of this study is to examine how the level of HIV is reduced in the blood when anti-HIV therapy is initiated. This study will also evaluate whether adding GM-CSF or IL-12 to the anti-HIV drug regimen will increase the rate that HIV is reduced. The anti-HIV drugs used in this study will include lamivudine (3TC), zidovudine (ZDV), indinavir (IDV), nevirapine (NVP), and stavudine (d4T). All have been used successfully to treat HIV. GM-CSF has been used to treat certain blood disorders; it will be used as an experimental drug in this study. IL-12 (interleukin-12) is a protein found naturally in the body that is thought to boost the immune system. Although GM-CSF and IL-12 have no direct effect against HIV, these drugs may improve the ability of the immune system to fight the virus.

Timeline

Start
Primary completion
Completion
2000-10

Drugs

EvaluationDrugModalityDoseRoute
Subject INDINAVIR ANHYDROUS Other / unclassified
Subject Lamivudine/Zidovudine Unknown
Subject Nevirapine Small molecule
Subject Stavudine Other / unclassified
Subject interleukin-12 Protein / enzyme biologic
Subject sargramostim Protein / enzyme biologic
Background Hepatitis A Vaccine (Inactivated) Vaccine