NCT00113126

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
526

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 6, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

November 29, 2006

Status Verified

June 1, 2005

First QC Date

June 3, 2005

Last Update Submit

November 28, 2006

Conditions

HIV InfectionAIDS

Keywords

Scheduled treatment interruptionsSTI

Outcome Measures

Primary Outcomes (2)

  • Amounts of drugs used

  • Response of viral load to retreatment after interruption

Secondary Outcomes (4)

  • Opportunistic infections and deaths

  • Adverse effects

  • CD4 counts

  • Resistance development

Interventions

Treatment interruptionDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Infectious Diseases Unit - University Hospital

Geneva, 1205, Switzerland

Location

Related Publications (4)

  • Ananworanich J, Nuesch R, Le Braz M, Chetchotisakd P, Vibhagool A, Wicharuk S, Ruxrungtham K, Furrer H, Cooper D, Hirschel B, Bernasconi E, Cavassini M, Ebnother C, Fagard C, Genne D, Khanna N, Perrin L, Phanupak P, Ubolyam S, Vernazza P, Yerly S; Swiss HIV Cohort Study. Failures of 1 week on, 1 week off antiretroviral therapies in a randomized trial. AIDS. 2003 Oct 17;17(15):F33-7. doi: 10.1097/00002030-200310170-00001.

    PMID: 14523294BACKGROUND

  • Ananworanich J, Gayet-Ageron A, Le Braz M, Prasithsirikul W, Chetchotisakd P, Kiertiburanakul S, Munsakul W, Raksakulkarn P, Tansuphasawasdikul S, Sirivichayakul S, Cavassini M, Karrer U, Genne D, Nuesch R, Vernazza P, Bernasconi E, Leduc D, Satchell C, Yerly S, Perrin L, Hill A, Perneger T, Phanuphak P, Furrer H, Cooper D, Ruxrungtham K, Hirschel B; Staccato Study Group; Swiss HIV Cohort Study. CD4-guided scheduled treatment interruptions compared with continuous therapy for patients infected with HIV-1: results of the Staccato randomised trial. Lancet. 2006 Aug 5;368(9534):459-65. doi: 10.1016/S0140-6736(06)69153-8.

    PMID: 16890832RESULT

  • Calmy A, Gayet-Ageron A, Montecucco F, Nguyen A, Mach F, Burger F, Ubolyam S, Carr A, Ruxungtham K, Hirschel B, Ananworanich J; STACCATO Study Group. HIV increases markers of cardiovascular risk: results from a randomized, treatment interruption trial. AIDS. 2009 May 15;23(8):929-39. doi: 10.1097/qad.0b013e32832995fa.

    PMID: 19425222DERIVED

  • Ananworanich J, Nuesch R, Cote HC, Kerr SJ, Hill A, Jupimai T, Laopraynak N, Saenawat S, Ruxrungtham K, Hirschel B. Changes in metabolic toxicity after switching from stavudine/didanosine to tenofovir/lamivudine--a Staccato trial substudy. J Antimicrob Chemother. 2008 Jun;61(6):1340-3. doi: 10.1093/jac/dkn097. Epub 2008 Mar 12.

    PMID: 18339636DERIVED

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeSexually Transmitted Diseases

Interventions

Treatment Interruption

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Treatment Adherence and ComplianceAttitude to HealthDelivery of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Bernard Hirschel, MD

    Infectious Diseases Unit - University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 3, 2005

First Posted

June 6, 2005

Study Start

January 1, 2002

Study Completion

October 1, 2005

Last Updated

November 29, 2006

Record last verified: 2005-06

Locations

CH(1)