Status:
COMPLETED
Structured Treatment Interruptions in Chronic HIV Infection
Lead Sponsor:
Istituto Superiore di Sanità
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 STI...
Detailed Description
Patients are randomized in a 1 to 1 ratio to continue their current antiretroviral regimen (Arm A) or to undergo structured treatment interruptions (STI) (Arm B) according to the following scheme: STI...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2001
Trial Type :
INTERVENTIONAL
End Date :
June 1 2004
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00324103
Start Date
June 1 2001
End Date
June 1 2004
Last Update
May 10 2006
Active Locations (1)
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1
Istituto Superiore di Sanità
Rome, Italy, 00161