Eighth International Congress on Drug Therapy in HIV Infection Glasgow, UK - 12-16 November 2006

Int Cong Drug Therapy HIV 2006 Nov 12-16;8:Abstract No. PL8.2

D Tumukunde, G Lillian, S Mutsai, R Nalumenya, J Komunyena, D Nsibambi, M Machingura, A Burke, on behalf of the DART Trial Team
Joint Clinical Research Centre, Kampala, Uganda; MRC/UVRI Programme on AIDS, Entebbe, Uganda; University of Zimbabwe, Harare, Zimbabwe; MRC Clinical Trials Unit, London, UK

PURPOSE OF THE STUDY: Following early termination of a comparison of fixed cycle STI versus continuous therapy (CT) in the DART trial, participants perceptions of STI were explored.

METHODS: 813 patients from 3 sites (2 Uganda, 1 Zimbabwe) with CD4≥300 after 48 or 72 weeks on ART were randomised to STI (n=408) or CT (405). Following DSMC review, the STI/CT randomisation was terminated on 15 March 2006 (median follow-up 51 weeks) and all patients were offered continuous ART. STI patients completed a questionnaire to assess their reactions to the STI strategy.

SUMMARY OF RESULTS: 12 patients had been lost to follow-up (n=7) or died (5) before 15/3/2006: 359 (91%) of the remaining 396 completed the questionnaire. Participants felt that STIs “made things a little\lot easier” in 32%, “a little\lot harder” in 36%, and “made no difference” in 31%. When restarting ART, some patients reported problems sometimes\frequently remembering to take drugs (8%), with drug timing (12%), taste (12%), or side-effects (25%). While 42% and 38% said they felt anxious or ill during STIs, 37% said they felt better during STIs; 19% did not want to restart ART. 28% made extra clinic visits during STIs. Qualitative comments highlighted minor HIV-related non-WHO events (e.g. lethargy, itching, rash, sores, appetite loss, fever) in those with problems. Although the trial was terminated because of greater disease progression in the STI arm, 62% were willing to interrupt ART again under medical supervision (47%, 65%, 67% in those having 1, 2 and 3+ STI cycles).

CONCLUSIONS: Although the STI strategy in DART was associated with a 2.6-fold increase in disease progression compared to CT, the absolute rate was low with the majority (92%) able to take ART intermittently without developing WHO 4 events. Around 40% of patients reported problems with STI: but a sizeable minority (around 30%) perceived fixed cycle STIs as having some advantages. Identification of predictors of poor response to STI and strategies with lower risks remains important.

Plenary Session: Oral Papers

2006-11-12
PL8.2

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