Structured Treatment Interruptions in Chronic HIV Infection

This study has been completed.
Sponsor:
Information provided by:
Istituto Superiore di Sanità
ClinicalTrials.gov Identifier:
NCT00324103
First received: May 8, 2006
Last updated: NA
Last verified: October 2005
History: No changes posted
  Purpose

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.


Condition Intervention Phase
HIV Infection
Drug: Structured Treatment Interruptions
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Antiretroviral Treatment With Structured Treatment Interruptions (STI) Versus Continuous Antiretroviral Treatment in HIV+ Patients With Persistent Suppression of Viral Replication

Resource links provided by NLM:


Further study details as provided by Istituto Superiore di Sanità:

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

Secondary Outcome Measures:
  • 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
  • HIV-related events.

Estimated Enrollment: 600
Study Start Date: June 2001
Estimated Study Completion Date: June 2004
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: STIs of 1, 1, 2, 2 and 3 months each followed by a 3-month therapy period.

During STIs, therapy is resumed in the presence of an HIV-RNA rebound > 50,000 copies/ml or of a CD4+ T cell decline > 25% of the baseline count (> 35% for patients with CD4+ > 500/mm3 at randomization). After the first cycle, subsequent STIs are performed only if an HIV-RNA level < 400 copies/ml is reached after 2 months of therapy resumption.

At the time of treatment interruptions patients in arm B who are on treatment with non-nucleoside reverse transcriptase inhibitors suspend these drugs first and continue the treatment with the other drugs of the combination for 3 days if nevirapine-treated and for 6 days in case of previous efavirenz-based regimen.

Patients are seen at the clinical site every three months for arm A and monthly for arm B. On these occasions, blood samples are obtained for biochemical and viro-immunological assessments.

The toxicity grading scale of the AIDS Clinical Trial Group (ACTG) is used for the reporting of clinical and laboratory adverse events.

In arm B, plasma genotype is obtained in samples taken after 15 or 30 days of drug suspension.

Patients will discontinue the study in case of : early therapy resumption for 2 consecutive times (only arm B patients); acute retroviral syndrome (only for arm B patients); AIDS-defining event; severe adverse event; pregnancy; non-compliance; patient’ s request; physician’s decision.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324103

Locations
Italy
Istituto Superiore di Sanità
Rome, Italy, 00161
Sponsors and Collaborators
Istituto Superiore di Sanità
Investigators
Study Chair: Stefano Vella, MD Istituto Superiore di Sanità
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00324103     History of Changes
Other Study ID Numbers: ISS PART
Study First Received: May 8, 2006
Last Updated: May 8, 2006
Health Authority: Italy: Istituto Superiore di Sanità

Keywords provided by Istituto Superiore di Sanità:
HIV
Chronic Infection
Clinical Trial
Structured Treatment Interruption

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 22, 2014