BASTA Study on STI in HIV Infected Patients

This study has been completed.
Sponsor:
Information provided by:
A.O. Ospedale Papa Giovanni XXIII
ClinicalTrials.gov Identifier:
NCT00310245
First received: March 31, 2006
Last updated: July 21, 2006
Last verified: November 2005
  Purpose

This is a single center, independent study. The primary objective is to compare efficacy and safety of continuing a conventional HAART in chronically infected HIV patients with a therapeutic strategy based on long term, immunologically driven treatment interruptions. Evaluation will be based on clinical, immunological and virological response.

Patients will be randomized in a ratio 1:2 to one of the two treatment arms:

Control group continuing the ongoing therapy STI group performing long term CD4 guided structured treatment interruptions In the STI arm patients will stay off therapy until their CD4 count will drop < 400 cells/mcL. At that time point patients will resume the HAART regimen they were assuming before STI and will continue HAART until they CD4 count will raise > 800 cells/mcL and their HIV-RNA will drop below the detection limit of 50 copies/ml. When both the CD4 count and the viral load will be within these pre-set values they will stop therapy again. There is no limit to the number of interruptions and re-start cycles during the study period The study is powered to evaluate equivalence between the two strategies under the assumption of a failure proportion in the control arm at each time point not greater than 5% and a maximum allowed difference of 15%.


Condition Intervention Phase
HIV Infection
Procedure: STI (structured Treatment Interruption)
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: Strategic Long Term, Immunologically Driven Treatment Interruptions in Patients on Effective HAART: a Controlled, Randomized Study

Resource links provided by NLM:


Further study details as provided by A.O. Ospedale Papa Giovanni XXIII:

Primary Outcome Measures:
  • Proportion of subjects maintaining at each time-point a CD4 + cell count above 400 cells/mcL.
  • Occurrence of clinical end-points (AIDS defining event and death)
  • Virologic failure with the selection of resistance conferring mutations.

Secondary Outcome Measures:
  • Mean variation of blood cholesterol and triglycerides from baseline values. For these parameters the proportion of subjects with a value above grade 2 (AHA) will be also used as evaluation criteria.
  • Development of lipodystrophy or modification of a pre-existing lipodystrophy
  • Time off therapy
  • Economic evaluation
  • Genotypic tests to be performed in the case of HIV-RNA > 1000 copies/ml while on therapy for at least 4 months or one month after each treatment interruption.

Estimated Enrollment: 130
Study Start Date: November 2000
Estimated Study Completion Date: November 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

i. Age > 17 years ii. Informed consent signed iii. Effective ongoing treatment (HIV-RNA < 50 copies/ml). Treatment must be based on any triple drug therapy. Patients must be on the same steady therapy for at least 3 months.

iv. Current CD4 cell count above 800 cells/L

Exclusion Criteria:

i. Childbearing or breastfeeding. Women of childbearing potential will be asked to adopt effective contraceptive methods or behaviors ii. Any ongoing grade 4 (WHO) AE or laboratory abnormality with the exclusion of cholesterol, triglycerides for which a grade 3 (AHA) level will be considered an exclusion criteria.

iii. Previous use of immunomodulatory agents

  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: NCT00310245

Locations
Italy
Antiviral Therapy Unit, Ospedali Riuniti
Bergamo, Italy, 24128
Sponsors and Collaborators
A.O. Ospedale Papa Giovanni XXIII
Investigators
Principal Investigator: Franco Maggiolo, MD Ospedali Riuniti, Bergamo
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00310245     History of Changes
Other Study ID Numbers: BG01
Study First Received: March 31, 2006
Last Updated: July 21, 2006
Health Authority: Italy: National Institute of Health

Keywords provided by A.O. Ospedale Papa Giovanni XXIII:
CD4-guided STI
Keywords:
HAART
Clinical outcome
Resistance
Costs
Prognostic factors
pulse therapy
treatment experienced
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 September 30, 2014