Raltegravir And Darunavir Antiretroviral in Antiretroviral Naive Patients

Phase 4 Completed 85 enrolled Dallas VA Medical Center Merck Sharp & Dohme LLC · collab Tibotec Pharmaceutical Limited · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether a combination of raltegravir and darunavir is as effective as standard regimens in the treatment of HIV-infected patients who have not previously used antiretroviral drug (treatment naive)

Timeline

Start: 2009-01
Primary completion: 2012-10
Completion: 2012-12

Outcome

Missed primary endpoint

paper The NRTI-sparing regimen RAL+DRV/r did not achieve similar week 48 virologic efficacy compared with TDF/FTC+DRV/r, but was better with regard to markers of bone health. PMID 25170938 ↗

paper Using an intention-to-treat analysis, 62.5% of RAL subjects and 83.7% of TDF/FTC subjects were responders (VL<48 copies/mL) at week 48 (p = 0.045; chi-square test). PMID 25170938 ↗

Publications

Bedimo RJ, Drechsler H, Jain M, Cutrell J, Zhang S, Li X, Farukhi I, Castanon R, Tebas P, Maalouf NM. The RADAR study: week 48 safety and efficacy of RAltegravir combined with boosted DARunavir compared to tenofovir/emtricitabine combined with boosted darunavir in antiretroviral-naive patients. Impact on bone health. PLoS One. 2014 Aug 29;9(8):e106221. doi: 10.1371/journal.pone.0106221. eCollection 2014.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Raltegravir	Other / unclassified	400 mg	Oral
Comparator	Tenofovir	Small molecule	300 mg	Oral
Comparator	emtricitabine	Other / unclassified	200 mg	Oral
Background	Darunavir	Small molecule	800 mg	Oral
Background	Ritonavir	Other / unclassified	100 mg	—