Efficacy Study of Substitution of Darunavir/Ritonavir (DRV/r) for Dual-boosted Protease Inhibitors
Information source: Community Research Initiative of New England
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Darunavir (DRV/r) (Drug); continue on current dual boosted PI (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Community Research Initiative of New England Official(s) and/or principal investigator(s): Calvin J Cohen, MD, MSc, Principal Investigator, Affiliation: CRI
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.
Clinical Details
Official title: A Randomized, Controlled Trial to Evaluate the Efficacy of Substituting Darunavir/Ritonavir (DRV/r) for Dual-boosted Protease Inhibitors in Individuals With Virologic Suppression for at Least 12 Weeks
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The Percentage of Participants With Successful Virologic Suppression
Secondary outcome: Economic Impact of a Substitution of Dual Boosted PIs With DRV/rLipid Fraction Results, Mean of the Change From Baseline to Week 24. Treatment Satisfaction (+3, Much More Satisfied Now to -3, Much Less Satisfied Now)
Detailed description:
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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).
Locations and Contacts
Spectrum Medical Group, Phoenix, Arizona 85012, United States
AIDS Healthcare Foundation, Los Angeles, California 02319, United States
Orlando Immunology Center, Orlando, Florida, United States
Community Research Initiative of New England, Boston, Massachusetts 02215, United States
Albany Medical Center, Albany, New York 12208, United States
Additional Information
Web page of CRI, the nonprofit research group sponsoring the study
Starting date: October 2007
Last updated: February 9, 2012
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