Structured Treatment Interruptions in Chronic HIV Infection

NCT00324103 | Completed Phase 3

• 1 other identifier: ISS PART
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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 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.

Conditions

HIV Infection

Keywords

HIV; Chronic Infection; Clinical Trial; Structured Treatment Interruption

Outcome Measures

Primary Outcomes (1)

• proportion of patients with CD4+ cell count above 500/mm3 at the end of follow-up (2 years) in the two treatment arms.

Secondary Outcomes (6)

• occurrence of grade 3 or 4 adverse events (clinical and laboratory)

• proportion of patients with HIV-RNA < 400 copies/ml at the end of follow-up

• proportion of patients with CD4+ cell count > 350/mm3 at the end of follow-up

• rate of virological failure

• emergence of resistance

Interventions

Structured Treatment Interruptions DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Superiore di Sanità: lead

Study Sites (1)

Istituto Superiore di Sanità

Rome, 00161, Italy

Location

MeSH Terms

Conditions

HIV Infections; Persistent Infection

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefano Vella, MD

  Istituto Superiore di Sanità

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 8, 2006
• First Posted: May 10, 2006
• Study Start: June 1, 2001
• Study Completion: June 1, 2004
• Last Updated: May 10, 2006

Record last verified: 2005-10

Locations

IT (1)