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Sponsored by: |
University Hospital, Geneva |
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Information provided by: | University Hospital, Geneva |
ClinicalTrials.gov Identifier: | NCT00113126 |
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 | Intervention |
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HIV Infection AIDS |
Drug: Treatment interruption |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Trial of CD4 Guided Treatment Interruption, Compared to Continuous Treatment, for HIV Infection |
Estimated Enrollment: | 526 |
Study Start Date: | January 2002 |
Estimated Study Completion Date: | October 2005 |
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:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Switzerland | |
Infectious Diseases Unit - University Hospital | |
Geneva, Switzerland, 1205 |
Study Chair: | Bernard Hirschel, MD | Infectious Diseases Unit - University Hospital |
Study ID Numbers: | SHCS # 356 |
Study First Received: | June 3, 2005 |
Last Updated: | November 28, 2006 |
ClinicalTrials.gov Identifier: | NCT00113126 |
Health Authority: | Switzerland: Swissmedic |
Scheduled treatment interruptions STI |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Communicable Diseases RNA Virus Infections Slow Virus Diseases |
Immune System Diseases Lentivirus Infections Infection |