Unknown

Dataset Information

0

Three-year safety and efficacy of vicriviroc, a CCR5 antagonist, in HIV-1-infected treatment-experienced patients.


ABSTRACT: BACKGROUND:Vicriviroc, an investigational CCR5 antagonist, demonstrated short-term safety and antiretroviral activity. METHODS:Phase 2, double-blind, randomized study of vicriviroc in treatment-experienced subjects with CCR5-using HIV-1. Vicriviroc (5, 10, or 15 mg) or placebo was added to a failing regimen with optimization of background antiretroviral medications at day 14. Subjects experiencing virologic failure and subjects completing 48 weeks were offered open-label vicriviroc. RESULTS:One hundred eighteen subjects were randomized. Virologic failure (<1 log10 decline in HIV-1 RNA > or =16 weeks postrandomization) occurred by week 48 in 24 of 28 (86%), 12 of 30 (40%), 8 of 30 (27%), 10 of 30 (33%) of subjects randomized to placebo, 5, 10, and 15 mg, respectively. Overall, 113 subjects received vicriviroc at randomization or after virologic failure, and 52 (46%) achieved HIV-1 RNA <50 copies per milliliter within 24 weeks. Through 3 years, 49% of those achieving suppression did not experience confirmed viral rebound. Dual or mixed-tropic HIV-1 was detected in 33 (29%). Vicriviroc resistance (progressive decrease in maximal percentage inhibition on phenotypic testing) was detected in 6 subjects. Nine subjects discontinued vicriviroc due to adverse events. CONCLUSIONS:Vicriviroc seems safe and demonstrates sustained virologic suppression through 3 years of follow-up. Further trials of vicriviroc will establish its clinical utility for the treatment of HIV-1 infection.

SUBMITTER: Wilkin TJ 

PROVIDER: S-EPMC2917795 | biostudies-literature | 2010 Aug

REPOSITORIES: biostudies-literature

altmetric image

Publications

Three-year safety and efficacy of vicriviroc, a CCR5 antagonist, in HIV-1-infected treatment-experienced patients.

Wilkin Timothy J TJ   Su Zhaohui Z   Krambrink Amy A   Long Jianmin J   Greaves Wayne W   Gross Robert R   Hughes Michael D MD   Flexner Charles C   Skolnik Paul R PR   Coakley Eoin E   Godfrey Catherine C   Hirsch Martin M   Kuritzkes Daniel R DR   Gulick Roy M RM  

Journal of acquired immune deficiency syndromes (1999) 20100801 5


<h4>Background</h4>Vicriviroc, an investigational CCR5 antagonist, demonstrated short-term safety and antiretroviral activity.<h4>Methods</h4>Phase 2, double-blind, randomized study of vicriviroc in treatment-experienced subjects with CCR5-using HIV-1. Vicriviroc (5, 10, or 15 mg) or placebo was added to a failing regimen with optimization of background antiretroviral medications at day 14. Subjects experiencing virologic failure and subjects completing 48 weeks were offered open-label vicriviro  ...[more]

Similar Datasets

| S-EPMC5916460 | biostudies-literature
| S-EPMC3321258 | biostudies-literature
| S-EPMC6748491 | biostudies-literature
| S-EPMC3320651 | biostudies-literature
| S-EPMC4502989 | biostudies-literature
| S-EPMC4604048 | biostudies-literature
| S-EPMC3552433 | biostudies-literature
| S-EPMC8607567 | biostudies-literature
| S-EPMC7899216 | biostudies-literature
| S-EPMC8270511 | biostudies-literature