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

• Status: Completed
• Trial end date: 2000-10-01

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.

• Phase: N/A

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Indinavir; Interleukin-12; Lamivudine; Lamivudine, zidovudine drug combination; Nevirapine; Sargramostim; Stavudine; Zidovudine