safety and effectiveness of raltegravir plus darunavir/ritonavir in treatment-naive hiv-infected adults

Conditions: HIV-1 Infections

Summary: the purpose of this study is to assess the effectiveness and safety of an antiretroviral therapy (art) regimen consisting of raltegravir (ral) and darunavir (drv)/ritonavir (rtv) as first-line therapy in treatment-naïve participants.

despite the remarkable strides made in the treatment of hiv-1-infected persons over the last decade, current first-line art regimens are imperfect. the ideal combination, unlike some current first-line options, would have uncompromised efficacy in the presence of transmitted drug-resistant variants. the primary purpose of this study is to estimate the cumulative proportion of art-naive participants experiencing virologic failure at or prior to week 24 after initiating raltegravir (ral) plus darunavir/ritonavir (drv/rtv). the study will last 52 weeks. all participants will follow the same treatment schedule and take ral plus drv/rtv orally daily for the duration of the trial. after entry, all participants will have scheduled visits at weeks 1, 4, 12, 24, 36, 48, and 52. medical/medication history, blood and urine collection, and liver function tests will occur at screening. a targeted physical exam and concomitant medications history will occur at all study visits. blood and urine collection and liver function tests will occur at most study visits. for females, a pregnancy test will occur at screening and study entry. ral and drv were provided by the study. rtv was not provided by the study.

Eligibility criteria:
inclusion criteria: * hiv-1-infected * plasma hiv-1 rna of at least 5,000 copies/ml within 90 days prior to study entry * hiv genotype (for reverse transcriptase and protease) performed at any time prior to study entry. more information on this criterion can be found in the protocol. * arv drug-naive. more information on this criterion can be found in the protocol. * negative result from a hepatitis b surface antigen test performed within 90 days prior to study entry * agree to use one form of medically-accepted contraceptive throughout the study and for 60 days after stopping study treatment. more information on this criterion can be found in the protocol. exclusion criteria: * serious illness requiring systemic treatment and/or hospitalization for at least 7 days prior to study. more information on this criterion can be found in the protocol. * screening hiv genotype obtained any time prior to study entry with more than one drv resistance-associated mutation \[ram\] (v11i, v32i, l33f, i47v, i50v, i54l, i54m, t74p, i84v, and l89v) or l76v alone * known major integrase inhibitor ram(s), including n155h, q148h/r/k, y143c/r, and g140s * severe renal insufficiency requiring hemodialysis or peritoneal dialysis * treatment with immunomodulators within 30 days prior to study entry. more information on this criterion can be found in the protocol. * current medications that are prohibited with any study medications. more information on this criterion can be found in the protocol. * known allergy/sensitivity to study drugs or their formulations. a history of sulfa allergy is not an exclusion. * active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with the study. * certain abnormal laboratory results. more information on this criterion can be found in the protocol. * pregnant or breastfeeding

Keywords: treatment naive