efficacy study of substitution of darunavir/ritonavir (drv/r) for dual-boosted protease inhibitors

Conditions: HIV Infections

Summary: this study will evaluate patients who have achieved virologic suppression (\< 400 copies/ml) on any dual protease inhibitor (pi) combination, to determine whether patients can substitute both pis with the single boosted pi darunavir given 600/100 ritonavir (rtv) twice daily (bid) and maintain comparable virologic suppression (% \< 50 c/ml) for 24 weeks.

the purpose of this study is to determine if patients who have achieved virologic suppression (\< 400 copies/ml) on any dual pi combination, can substitute both pis with the single boosted pi darunavir given 600/100 rtv bid and maintain comparable virologic suppression (% \< 50 c/ml) for 24 weeks. randomized, non-blinded, multicenter, 48 week, controlled trial to assess the non-inferiority of substituting drv/r for a dual boosted pi combination in patients with stable virologic suppression on a regimen containing a dual boosted pi combination plus at least one additional fda-licensed antiretroviral agent from another class. participants will be randomized (1:1) to one of the included treatment arms.

Eligibility criteria:
inclusion criteria: * age 18 years or older * treatment with a stable antiretroviral regimen containing two protease inhibitors, one additional fda-licensed agent from another class (except nnrtis) and a boosting dosage of ritonavir (100 bid or qd) for at least 12 weeks prior to screening * no plans to make any changes in hiv treatment regimen (other than those required by study) in the next 48 weeks. * hiv-1 rna \< 400 copies/ml based on the most recent value done as part of routine care at least 12 weeks prior to screening; and \< 400 at screening * any cd4 count is allowed * written informed consent to participate exclusion criteria: * current regimen includes an nnrti * cdc class c illness diagnosed within 30 days of screening * lab abnormalities as defined by a standardized grading scheme based on the daids table * any grade 3 or 4 toxicity with the following exceptions: * pre-existing diabetes with glucose elevations ≥ grade 3 * triglyceride or total cholesterol elevations ≥ grade 3 * clinical or laboratory evidence of clinically significant liver impairment/dysfunction, disease or cirrhosis note: individuals co-infected with chronic hepatitis b or c will be allowed to enter the trial if their condition is clinically stable. individuals diagnosed with acute viral hepatitis at screening will not be allowed to enroll during acute phase. * active substance abuse or significant psychiatric illness that in the opinion of the investigator might interfere with study compliance. * use of any investigational agents 30 days prior to screening * life expectancy \< 6 months in the opinion of the investigator * prior use of darunavir or known allergy to any of the components of darunavir * breast feeding * female subject of childbearing potential not using effective non-hormonal birth control methods or not willing to continue practicing these birth control methods from screening until the last trial related activity. note: hormonal based contraception may not be reliable when taking darunavir, therefore to be eligible for this study, women of childbearing potential who may have vaginal intercourse should either: 1. use a double barrier method to prevent pregnancy (i.e., using a condom with either a diaphragm or cervical cap) or 2. use hormonal based contraceptives in combination with a barrier contraceptive (i.e., male condom, diaphragm, cervical cap or female condom) or 3. use an intra uterine device (iud) in combination with a barrier contraceptive (i.e., male condom, diaphragm, cervical cap or female condom) or 4. be non-heterosexually active, practice sexual abstinence or have a vasectomized partner (confirmed sterile).

Keywords: hiv/aids darunavir protease inhibitors dual boosted treatment experienced