Overview

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

Status:
Completed

Trial end date:
2005-10-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University Hospital, Geneva

Criteria

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.