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

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00113126
• Other study ID #: SHCS # 356
• Status: Completed
• Phase: N/A
• First received: June 3, 2005
• Last updated: November 28, 2006
• Start date: January 2002
• Est. completion date: October 2005

Study information

• Verified date: June 2005
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 526
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• AIDS
• HIV Infection
• HIV Infections
• Infection

Intervention

Drug:
• Treatment interruption

Locations

Country	Name	City	State
Switzerland	Infectious Diseases Unit - University Hospital	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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, Genné D, Nüesch R, Vernazza P, Bernasconi E, Leduc D, Satchell C, Y — View Citation

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, Ebnöther C, Fagard C, Genné 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amounts of drugs used
Primary	Response of viral load to retreatment after interruption
Secondary	Opportunistic infections and deaths
Secondary	Adverse effects
Secondary	CD4 counts
Secondary	Resistance development