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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — | — |