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BASTA Study on STI in HIV Infected Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00310245
Recruitment Status : Completed
First Posted : April 3, 2006
Last Update Posted : July 24, 2006
Information provided by:
A.O. Ospedale Papa Giovanni XXIII

Brief Summary:

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 or disease Intervention/treatment Phase
HIV Infection Procedure: STI (structured Treatment Interruption) Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Strategic Long Term, Immunologically Driven Treatment Interruptions in Patients on Effective HAART: a Controlled, Randomized Study
Study Start Date : November 2000
Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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

Secondary Outcome Measures :
  1. 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.
  2. Development of lipodystrophy or modification of a pre-existing lipodystrophy
  3. Time off therapy
  4. Economic evaluation
  5. 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00310245

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Antiviral Therapy Unit, Ospedali Riuniti
Bergamo, Italy, 24128
Sponsors and Collaborators
A.O. Ospedale Papa Giovanni XXIII
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Principal Investigator: Franco Maggiolo, MD Ospedali Riuniti, Bergamo
Publications of Results:
Layout table for additonal information Identifier: NCT00310245    
Other Study ID Numbers: BG01
First Posted: April 3, 2006    Key Record Dates
Last Update Posted: July 24, 2006
Last Verified: November 2005
Keywords provided by A.O. Ospedale Papa Giovanni XXIII:
CD4-guided STI
Clinical outcome
Prognostic factors
pulse therapy
treatment experienced
treatment interruption
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases