Efficacy Study of Substitution of Darunavir/Ritonavir (DRV/r) for Dual-boosted Protease Inhibitors
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Darunavir (DRV/r); continue on current dual boosted PI
Intervention description: Switch to DRV/r at a dose of 600/100 BID for 48 weeks; Continue on current dual boosted PI until week 24. At week 24, participants will be allowed to cross over to the DRV/r arm provided that they have maintained virologic suppression (< 400 copies/ml) for the first 24-weeks of the study and be followed for an additional 24 weeks
Intervention MeSH terms: Darunavir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV/AIDS; darunavir; Protease inhibitors; Dual boosted; Treatment experienced

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.
    

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).