Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT00551018
Brief Summary:
Vicriviroc (vye-kri-VYE-rock) is an investigational drug (not yet approved by Government Regulatory Authorities for commercial use) that belongs to a new class of drugs, called CCR5 receptor blockers. This group of drugs blocks one of the ways HIV enters T-cells (the cells that fight infection). Previous smaller studies in HIV treatment-experienced patients, have shown that vicriviroc is safe and effective. The purpose of this study is to evaluate the virologic efficacy of vicriviroc combined with ritonavir-boosted Reyataz® in HIV-infected treatment-naïve subjects.
Detailed Description:
This is a randomized, open-label, active-controlled, parallel-group, multi-center study of vicriviroc maleate in treatment-naïve subjects infected with CCR5-tropic HIV. The study will compare the virologic benefit of vicriviroc combined with ritonavir-boosted Reyataz to a control group receiving Truvada plus ritonavir-boosted Reyataz. Interim analyses will be performed when the first cohort of 80 subjects have completed 24 weeks and 48 weeks of treatment. The second cohort of 120 subjects will be enrolled after the first interim analysis; a third interim analysis will be performed when subjects in this second cohort have completed 24 weeks of treatment. The primary efficacy analysis will be conducted when all 200 subjects from both stages have completed 48 weeks of treatment or discontinued. The final analysis will be performed at Week 96, when all 200 subjects have completed 96 weeks of treatment or discontinued. If vicriviroc is shown to provide benefit at the studied dose, study participants in the vicriviroc arm who complete 96 weeks of treatment may continue in a protocol extension, where they will be offered vicriviroc free of charge until the drug is commercially available in their location or until the sponsor terminates the clinical development of vicriviroc.
Study:
NCT00551018
Study Brief:
Protocol Section:
NCT00551018