Mallolas J, Blanco JL, Sarasa M, Giner V, Martinez E, Garcia-Viejo MA, Arnaiz JA, Cruceta A, Soy D, Tuset M, Codina C, Pumarola T, Carne X, Gatell JM; Conference on Retroviruses and Opportunistic Infections.
7th Conf Retrovir Oppor Infect Jan 30 Feb 2 2000 Conf Retrovir Oppor Infect 7th 2000 San Franc Calif. 2000 Jan 30-Feb 2; 7: 172 (abstract no. 512).
Hosp. Clin., Barcelona, Spain.
Background: Strategies for treatment of HIV need to combine potency, safety and convenient dosing. However, regimens including once-daily protease inhibitors are not yet available. We have performed a pilot study to find an IND/RTV regimen for once-daily dosing, monitoring plasma levels. Methods: Antiretroviral-naive HIV infected adults were eligible. Therapy was (Combivir(R)) 1 pill bid plus IND/RIT (liquid formulation) 800/100 bid with food. At 4 weeks intervals plasma levels were measured and dosage of IND/RIT switched to 1000/100 qd and then 800/200 qd. If Cmin12h, levels of IND were too low (<0.1 microgram/ml) with IND/RIT 1000/100 qd in the first half of patients it was planned to switch directly to 800/200 qd in the second half. (Results: 27 patients were recruited. Mean baseline CD4 count was 107 (from 4 to 623). 11 (40%) discontinued the study medication within the first 4 weeks due to clinical progression (n=3) or grade 1-2 RTV related side effects (n=8). 9 (Group A) switched from 800/100 bid to 1000/100 qd and then to 800/200 qd. 7 switched directly to 800/200 qd. None developed grade 3-4 side effects. At week 12 viral load was <200 copies/ml in 12 of the 16 patients (75%). RTV levels were always below 2.1 micrograms/ml. IND in microgram/ml (mean and 95% CI) can be seen in the table. (Table: see text) Conclusion: The once-daily regimen of IND/RIT is feasible and deserves further evaluation in larger randomized trials. The liquid formulation of RIT was not well tolerated by our antiretroviral naive patients despite "baby" doses.
Publication Types:
Keywords:
- AIDS Vaccines
- Acquired Immunodeficiency Syndrome
- Adult
- CD4 Lymphocyte Count
- Combivir
- Drug Combinations
- HIV Infections
- HIV Seropositivity
- Humans
- Indinavir
- Infant
- Lamivudine
- Ritonavir
- Viral Load
- Zidovudine
Other ID:
UI: 102243390
From Meeting Abstracts