Efficacy Study of Substitution of Darunavir/Ritonavir (DRV/r) for Dual-boosted Protease Inhibitors

NCT ID: NCT00543101

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2010-02-28

Brief 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.

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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Switch to DRV/r

Switch to DRV/r at a dose of 600/100 BID for 48 weeks

Group Type: ACTIVE_COMPARATOR

Darunavir (DRV/r)

Intervention Type: DRUG

Switch to DRV/r at a dose of 600/100 BID for 48 weeks

Continue on Current Dual Boosted PI

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 are followed for an additional 24 weeks

Group Type: ACTIVE_COMPARATOR

continue on current dual boosted PI

Intervention Type: DRUG

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

Interventions

Darunavir (DRV/r)

Switch to DRV/r at a dose of 600/100 BID for 48 weeks

Intervention Type: DRUG

continue on current dual boosted PI

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 Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Community Research Initiative of New England

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Calvin J Cohen, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

CRI

Locations

Spectrum Medical Group

Phoenix, Arizona, United States

AIDS Healthcare Foundation

Los Angeles, California, United States

Orlando Immunology Center

Orlando, Florida, United States

Community Research Initiative of New England

Boston, Massachusetts, United States

Albany Medical Center

Albany, New York, United States

Countries

United States

Related Links

http://www.crine.org

Web page of CRI, the nonprofit research group sponsoring the study

Other Identifiers

07-142

Identifier Type: -

Identifier Source: org_study_id