AEGiS-13IAC: A randomized, controlled, open-label study comparing the adherence and convenience of continuing Indinavir Q8H vs Switching to norvir/indinavir 400 mg/400 mg BID (The NICE Study).

13th International AIDS Conference

Durban, South Africa - July 9-July 14, 2000

A randomized, controlled, open-label study comparing the adherence and convenience of continuing Indinavir Q8H vs Switching to norvir/indinavir 400 mg/400 mg BID (The NICE Study).

Int Conf AIDS 2000 Jul 9-14; 13:(abstract no. WeOrB482)

DeJesus E, Pistole M, Fetchick R, Lauermann M, Roland R, Garrett L, Jiang P, McMillan F
E. DeJesus, IDC Research Initiative, 499 East Central Parkway, Altamonte Springs, United States, Tel.: +407-647-39-60, Fax: +407-647-34-26, E-mail: IDCReach@aol.com

BACKGROUND: To evaluate the medication taking habits and preference of HIV-1 positive patients randomized to receive either Norvir (ritonavir) 400 mg BID plus indinavir 400 mg BID in combination with two licensed nucleoside reverse transcriptase inhibitors (NRTIs) versus continuing indinavir q8h plus two licensed NRTIs.

METHODS: Patients with HIV RNA >400 copies/mL were centrally randomized in this open-label multi-center study. A validated Medication-Taking Survey (MTS-6), consisting of questions addressing adherence and convenience, was to be administered at the baseline, Week 4, 12, and 24 visits to measure the effect of protease inhibitor (PI) regimen on daily life. Safety and efficacy were also evaluated.

RESULTS: Interim analysis of demographic data (N = 201) show 89% of patients were men, and 71% of patients were white. The mean age was 41 (range = 25-66 years). Adverse events leading to discontinuation to date have been 8% and 3% for Norvir/indinavir BID and indinavir q8h, respectively. The MTS-6 has been analyzed for the 110 patients who completed the Week 4 visit. Results showed that patients randomized to Norvir/indinavir BID reported missing fewer doses than they had reported missing prior to initiation of this regimen (p>.001). No effect was observed for patients randomized to remain on indinavir q8h (p = .74). Patients on Norvir/indinavir BID also reported that it was easier to take the PIs as prescribed, easier to take at the same time each day, and easier to coordinate with meals when compared to baseline (p>.001 in each case). Similar effects were not seen for patients on indinavir q8h (p>.40 in each case). No new safety issues have been reported.

CONCLUSIONS: Interim results show that after 4 weeks of treatment, patients remaining on Norvir/indinavir 400/400mg BID reported improved adherence and convenience as reflected in missing fewer doses, reporting it was easier to take the PIs with meals and at the same time each day.

Keywords: AEGIS, Indinavir, Ritonavir, Reverse Transcriptase Inhibitors, HIV Protease Inhibitors, HIV Infections, Anti-HIV Agents, HIV-1, CD4 Lymphocyte Count, HIV, 4-Acetamido-4'-isothiocyanatostilbene-2,2'-disulfonic, Acid, Laboratory Techniques and Procedures, 4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate, Human, Male, prevention & control
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