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
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
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- Primary completion
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- Completion
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |