BASTA Study on STI in HIV Infected Patients - Full Text View

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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Ospedali Riuniti di Bergamo:

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

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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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310245

Locations

Italy
Antiviral Therapy Unit, Ospedali Riuniti
Bergamo, Italy, 24128

Sponsors and Collaborators

Ospedali Riuniti di Bergamo

Investigators

Principal Investigator:

Franco Maggiolo, MD

Ospedali Riuniti, Bergamo

More Information

Publications:

Maggiolo F, Ripamonti D, Gregis G, Quinzan G, Callegaro A, Suter F. Effect of prolonged discontinuation of successful antiretroviral therapy on CD4 T cells: a controlled, prospective trial. AIDS. 2004 Feb 20;18(3):439-46.

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 Ospedali Riuniti di Bergamo:

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 March 07, 2013