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Staccato: A Trial of CD4 Guided Treatment Interruption, Compared to Continuous Treatment, for HIV Infection

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: NCT00113126
Recruitment Status : Completed
First Posted : June 6, 2005
Last Update Posted : November 29, 2006
Information provided by:
University Hospital, Geneva

Brief Summary:

Treatment of HIV repairs the immune system, but continuous treatment is expensive and causes side effects. Would it not be better to treat intermittently, e.g. stop treatment when the immune system has recovered, and start again only when damage reappears? That is the question which STACCATO proposes to answer.

Approximately 500 patients were recruited for this trial from 2002 to 2004. One third were treated continuously; in two thirds, the treatment was interrupted whenever the CD4 count, a measure of immune recovery, exceeded 350. At the end of 2005, the two treatment groups will be compared in order to see which fared better regarding amount of drugs used, side effects, CD4 counts, and development of resistance to treatment.

Condition or disease Intervention/treatment Phase
HIV Infection AIDS Drug: Treatment interruption Not Applicable

Detailed Description:

Continuous treatment has been very successful in diminishing the diseases and deaths caused by HIV. However, continuous treatment is expensive. Intermittent treatment will always cost less than continuous treatment, and therefore has the potential to facilitate access to highly active antiretroviral therapy (HAART) in developing countries. HAART also causes many undesirable effects. Intermittent treatment decreases exposure to drugs and is therefore expected to decrease side effects.

STACCATO is a randomised trial of intermittent versus continuous anti-retroviral treatment. At least 600 patients on HAART, with viremia below 50 copies/ml and CD4 count above 350 cells/ml were randomised to one of two arms, in 1:2 proportions:

  • Arm 1: Continuation (control) arm: Drugs are continued or changed according to current guidelines and good clinical practice.
  • Arm 2: CD4-guided arm: Drugs discontinued and reintroduced according to CD4 counts, with HAART being administered only if CD4 count is < 350 cells/ml.

Randomized treatment will continue during an average of approximately 2 years, and will be followed by a period of 12 to 24 weeks’ continuous treatment, for patients in both arms.

Endpoints: The amount of drugs used, side effects, viremia and CD4 counts, number of clinical events, at the end of the randomized treatment period, and again 12 to 24 weeks later. A subproject will study the effect of treatment interruption on resistance development, mutations in proviral DNA and proviral DNA levels.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 526 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of CD4 Guided Treatment Interruption, Compared to Continuous Treatment, for HIV Infection
Study Start Date : January 2002
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. Amounts of drugs used
  2. Response of viral load to retreatment after interruption

Secondary Outcome Measures :
  1. Opportunistic infections and deaths
  2. Adverse effects
  3. CD4 counts
  4. Resistance development

Information from the National Library of Medicine

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

Inclusion Criteria:

  • CD4 lymphocyte count above 350/microliter and viral HIV1-RNA below 50 copies/ml on antiretroviral treatment.

Exclusion Criteria:

  • Virologic failure of treatment. Failure of treatment defined as a treatment switch motivated by high viral loads on treatment.

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): NCT00113126

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Infectious Diseases Unit - University Hospital
Geneva, Switzerland, 1205
Sponsors and Collaborators
University Hospital, Geneva
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Study Chair: Bernard Hirschel, MD Infectious Diseases Unit - University Hospital

Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00113126     History of Changes
Other Study ID Numbers: SHCS # 356
First Posted: June 6, 2005    Key Record Dates
Last Update Posted: November 29, 2006
Last Verified: June 2005

Keywords provided by University Hospital, Geneva:
Scheduled treatment interruptions

Additional relevant MeSH terms:
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Communicable Diseases
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