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
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria

You may be eligible for this study if you:

• Are HIV-positive.

• Have a CD4 cell count greater than or equal to 300 cells/ml within 30 days prior to study entry.

• Have a plasma viral load (level of HIV in the blood) of greater than or equal to 20,000 copies/ml within 30 days of study entry.

• Are at least 18 years old.

• Agree to practice abstinence or use effective methods of birth control during the study.

Exclusion Criteria

You will not be eligible for this study if you:

• Have taken anti-HIV medication for more than 7 days.

• Have had known seroconversion within 6 months prior to study entry.

• Have any infection requiring treatment within 30 days prior to study entry.

• Have had a fever for 7 days in a row during the 30 days before study entry.

• Have cancer that requires chemotherapy.

• Are pregnant or breast-feeding.

• Are taking certain medications.