Structured Treatment Interruptions in Chronic HIV Infection

• Status: Completed
• Trial end date: 2004-06-01
• Target enrollment: 0
• Participant gender: All

Summary

In the last years Structured Treatment Interruptions (STI) have been proposed to reduce HAART-related toxicity and to increase patients' compliance. ISS PART is a randomized comparison of repeated STIs versus continuous HAART in chronically HIV-infected subjects with persistent suppression of viral replication. The two arms of the study will be compared in terms of immunological response (proportion of patients with CD4>500/mmc) at 2 years.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istituto Superiore di Sanità

Criteria

Inclusion Criteria:

• first-line antiretroviral therapy (3 or 4 drugs) for 6 to 18 months (one previous therapy change for toxicity or non-compliance is allowed)

• HIV-RNA level below 400 copies/ml for at least 6 months;

• CD4+ count > 350 /mm3;

• pre-HAART CD4+ > 100/mm3

• no previous AIDS diagnosis.

Exclusion Criteria:

• Previous antiretroviral therapy with 1 or 2 drugs (except ARV prophylaxis in pregnancy)

• Pregnancy or breastfeeding

• Previous diagnosis of AIDS

• Grade 3 or 4 adverse event in the 15 days before enrolment

• Neoplasia

• Previous therapy with IL-2, interferon (in the last 2 years) or experimental therapies