Clumeck N, Mundere J, Kabeya K, Barath A, De Cock F, Sommereijns B, Sprecher S, Hermans P, De Wit S; Conference on Retroviruses and Opportunistic Infections.

Program Abstr 6th Conf Retrovir Oppor Infect Conf Retrovir Oppor Infect 6th 1999 Chic Ill. 1999 Jan 31-Feb 4; 6th: 185 (abstract no. 627).

Belgium.

MIRO is a randomized open trial aiming to determine whether HIV viral suppression can be maintained with a double NRTI therapy after an induction phase with either triple or quadruple therapy (2 NRTI's + 1 or 2 PI's). Patients (p.) with CD4 cell count > 100/microliter and viral load (VL) > 5000 copies/ml were randomized to receive Indinavir (I) (800 mg TID) or Ritonavir (400 mg BID) + Saquinavir (400 mg BID) (R/S) in combination with 2 NRTI's, P. with a VL < 400 copies/ml at W12 were randomized at W16 to continue or interrupt PI(s). Primary end-points were VL < 400/ml at W12 and confirmed (at least twice) VL > 400 copies/ml after W16. Analysis was performed on intent to treat. Eighty five p. were randomized (I=42, R/S=43). Both groups were comparable for p. characteristics, median VL (4.9 log) and mean CD4 cell count (350 microliter). All p. were naive to the 2 NRTI's and to PI's. Fifty two (25 vs 27) were NRTI experienced. At week 12, plasma VL < 400 and < 50 copies/ml was achieved in respectively 72% and 22% in both induction groups. At week 16, 44 p. were randomized to continue (24) or to stop (20) PI(s). Both groups remained comparable for all characteristics. VL was < 50 copies in 23 p. (12 vs 11). There was a significant difference in the risk of recurrence of VL above 400 copies in p. followed for at least 20 weeks: 4/23 (17%) with PI vs 10/17 (59%) without PI. The risk of relapse without PI was also significantly higher even if considering p. with VL < 50 at W16: 1/12 vs 7/10. Median viral load at the time of relapse was similar in both groups (3.4 log). Conclusion: No difference was seen between the 2 induction regimens. Maintenance therapy with 2 NRTI's was less effective than continuous treatment with 2 NRTI's with PI even among p. who reached maximal viral suppression at W16. However, in case of failure, VL rebound is of low magnitude. Response to further treatment in relapsing p. will be presented.

Publication Types:

• Meeting Abstracts

Keywords:

• Acquired Immunodeficiency Syndrome
• Antiretroviral Therapy, Highly Active
• CD4 Lymphocyte Count
• Clinical Trials as Topic
• Drug Therapy, Combination
• HIV Infections
• Humans
• Indinavir
• Protease Inhibitors
• Ritonavir
• Saquinavir
• Treatment Outcome
• Viral Load
• drug therapy
• therapy

Other ID:

• 20711862

UI: 102195392

From Meeting Abstracts