drugset / Trial / NCT00006154

A Study to Evaluate the Use of a Protease Inhibitor and of Interleukin-2 (IL-2) in the Treatment of Early HIV Infection

NCT00006154

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to look at the effectiveness of combination anti-HIV drug therapy (with protease inhibitors \[PIs\] or without) in patients with early HIV infections. This study also looks at whether a drug called interleukin-2 (IL-2) can boost the immune system of these patients. Doctors are not sure which anti-HIV drug combination is best to use in patients who have early HIV infection and have never received anti-HIV treatment. PIs are anti-HIV drugs that decrease viral load (level of HIV in the blood). However, PIs can cause serious side effects in some patients. Doctors would like to know if a drug combination that does not contain a PI is just as good as one that contains PIs.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Abacavir Other / unclassified 300 mg
Subject Didanosine Small molecule 250 mg
Subject Didanosine Small molecule 400 mg
Comparator Efavirenz Other / unclassified 200 mg
Subject INDINAVIR ANHYDROUS Other / unclassified 400 mg
Subject Ritonavir Other / unclassified 100 mg
Comparator Stavudine Other / unclassified 60 mg
Comparator Stavudine Other / unclassified 80 mg
Subject aldesleukin Protein / enzyme biologic 1.5e+07 iu Subcutaneous