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

NCT00006154 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2013-09-06

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

DRUG

Indinavir sulfate

400 mg tablets equaling 1600 mg daily

DRUG

Ritonavir

100 mg liquid capsules equaling 400 mg daily

DRUG

Abacavir sulfate

300 mg capsules equaling 600 mg daily. Administration based on individual results after 16 weeks.

DRUG

Efavirenz

200 mg capsules equaling 600 mg daily

DRUG

Stavudine

30-40 mg capsules equaling 60 or 80 mg daily

DRUG

Didanosine

250-400 mg E.coated tablets equaling 250 or 400 mg daily

DRUG

Aldesleukin

Subcutaneous injection equaling 15 x 10\^6 IU daily dose. Administration based on individual results after 16 weeks and randomization.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Rafick-Pierre Sekaly

  • Brian Conway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00006154 on ClinicalTrials.gov