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

NCT00543101 | Completed Phase 4 Results DMC

• 1 other identifier: 07-142
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 5

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.

Conditions

HIV Infections

Keywords

HIV/AIDS; darunavir; Protease inhibitors; Dual boosted; Treatment experienced

Outcome Measures

Primary Outcomes (1)

• The Percentage of Participants With Successful Virologic Suppression

  Amount of HIV RNA copies per ml blood collected from subjects as measured by the Ultra-sensitive HIV-1 PCR (Roche Cobas). Successful virologic suppression is defined as \< 50 copies/ml blood. The result is the percentage of participants with successful virologic suppression.

  24 weeks

Secondary Outcomes (3)

• Economic Impact of a Substitution of Dual Boosted PIs With DRV/r

  48 weeks

• Lipid Fraction Results, Mean of the Change From Baseline to Week 24.

  baseline and 24 weeks

• Treatment Satisfaction (+3, Much More Satisfied Now to -3, Much Less Satisfied Now)

  24 weeks

Study Arms (2)

Switch to DRV/r

ACTIVE COMPARATOR

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

Drug: Darunavir (DRV/r)

Continue on Current Dual Boosted PI

ACTIVE COMPARATOR

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

Drug: continue on current dual boosted PI

Interventions

Darunavir (DRV/r) DRUG

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

Switch to DRV/r

continue on current dual boosted PI 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

Continue on Current Dual Boosted PI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Use a double barrier method to prevent pregnancy (i.e., using a condom with either a diaphragm or cervical cap) Or

Sponsors & Collaborators

• Community Research Initiative of New England: lead

Study Sites (5)

Spectrum Medical Group

Phoenix, Arizona, 85012, United States

Location

AIDS Healthcare Foundation

Los Angeles, California, 02319, United States

Location

Orlando Immunology Center

Orlando, Florida, United States

Location

Community Research Initiative of New England

Boston, Massachusetts, 02215, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Related Links

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

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Darunavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The foremost problem was the small number of participants enrolled. By the time we were open for enrollment, most clinicians in the community had already switched their patients from dual boosted regimens to darunavir/ritonavir.

Results Point of Contact

• Title: Clavin Cohen MD
• Organization: Community Research Initiative of New England (CRINE)

ccohen@crine.org

617 502 1700

Study Officials

• Calvin J Cohen, MD, MSc

  CRI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2007
• First Posted: October 12, 2007
• Study Start: October 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: July 21, 2017
• Results First Posted: August 17, 2010

Record last verified: 2017-07

Locations

US (5)