DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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/r

Lipid 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017