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Evaluation of Low-dose Darunavir in a Switch Study (DRV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02671383
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : June 26, 2018
Medical Research Council, South Africa
Information provided by (Responsible Party):
Willem Daniel Francois Venter, University of Witwatersrand, South Africa

Brief Summary:
This is a switch study to assess the non-inferiority (in terms of efficacy and safety) of darunavir (boosted with ritonavir, DRV/r 400mg/100mg daily) when compared with lopinavir (boosted with ritonavir, LPV/r total dose 800mg/200mg daily), in combination with a nucleoside backbone, administered as a second line therapy in HIV positive individuals.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Darunavir Drug: Lopinavir Phase 3

Detailed Description:
This is an open label randomised, parallel group, phase 3b, switch study to demonstrate non-inferiority of low-dose boosted darunavir (DRV/RTV 400/100 mg once daily) compared with boosted lopinavir-based (LPV/RTV 800/200 mg daily) second-line regimens when administered over 48 weeks in combination with two nucleos(t)ide reverse transcriptase inhibitors in patients infected with HIV-1 who are virologically suppressed and stable on a standard second-line regimen. All medications will be provided in an open-label design. Patients who are virologically suppressed and stable on a standard second-line regimen will be recruited for the study. There are concerns that switching these patients may result in virological failure as the study aimed at demonstrating non-inferiority of darunavir compared with Lopinavir. In such cases, the investigator will ensure that virological failures are investigated and patients are switched back to standard of care immediately. Participants will be patients who are receiving HIV treatment in public clinics. Interested patients will be invited to the study, information given, and only those who will give written informed consent will be screened, and if eligible enrolled into the study. Each enrolled participant will be follow-up at week 4, 12, 24, 36, and 48 (exit visit) from enrolment date. Data will be collected using ethics-approved worksheets, and captured into REDCap. The data manager will ensure data are correct and complete by performing data verifications - physical and electronic. Internal quality control will be performed by dedicated staff based on the study quality plan to be implemented. The external study monitor will perform 100% eligibility checks on all signed informed consents in addition to other source verifications during her periodic site visits according to the monitoring plan to be implemented. Findings from the monitor will be implemented in the form of data/procedure corrections per good clinical practice, and all relevant staff trained and documented accordingly. Participants' records will be coded and stored in a lockable cabinet. Only study staff will have access to participants' records. All electronic documents relating to the study will be stored in password-protected computers and only accessible to study staff. Study staff are not allowed to share password among themselves or with anyone outside the study team. Designed in non-inferiority fashion, this study will enrol approximately 300 participants for 80% power to detect a 10% non-inferiority margin in the per protocol (PP) analysis. A Data Safety Management Board (DSMB) will oversee and review the interim data report. At the close of the study, results will be disseminated to participants, and the scientific community, as well as updated on

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised, Open Label Switch Study Comparing Darunavir/Ritonavir 400mg/100mg Daily With Lopinavir/Ritonavir 800mg/200mg Daily, in HIV-positive Participants
Actual Study Start Date : June 30, 2016
Actual Primary Completion Date : May 16, 2018
Actual Study Completion Date : May 16, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Darunavir
Darunavir/Ritonavir 400/100mg once daily
Drug: Darunavir
Darunavir/ritonavir 400/100mg (DRV/r) once daily plus nucleoside/nucleotide reverse transcriptase inhibitors.
Other Name: Boosted darunavir (DRV/r)

Active Comparator: Lopinavir
Lopinavir/Ritonavir 400/100mg twice daily
Drug: Lopinavir
Lopinavir/ritonavir 400/100mg (LPV/r) twice daily plus nucleoside/nucleotide reverse transcriptase inhibitors.
Other Name: Boosted lopinavir (LVP/r)

Primary Outcome Measures :
  1. Number of participants with undetectable HIV-1 RNA levels [ Time Frame: Week 48 ]
  2. Number of participants with certain adverse events related to the treatment [ Time Frame: Week 48 ]

Secondary Outcome Measures :
  1. Time to virologic failure [ Time Frame: Week 48 ]

Other Outcome Measures:
  1. Lipids measure [ Time Frame: Baseline, Week 24 and 48 ]
  2. Fasting glucose measure [ Time Frame: Baseline and Week 48 ]
  3. Creatinine clearance measure [ Time Frame: Baseline, Week 12, 24, and 48 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Participant is aged ≥18 years
  • Participant weight >40kg
  • Participant is on a LPV/r-containing regimen for at least 6 months with no history of other protease inhibitors
  • Participant has a plasma HIV-1 RNA level <50 copies/mL in the last 60 days
  • Participant is informed and has the ability to comprehend the full nature and purpose of the study, and give voluntary written informed consent before inclusion in the study

Exclusion Criteria:

  • Participants who are taking any antiretrovirals other than nucleoside/nucleotide reverse transcriptase inhibitors and LPV/r
  • Any prior history of genotype-documented protease inhibitor resistance
  • Participants who are taking rifampicin or any other therapy with major cytochrome P450 interactions, within the last month
  • Participants who are allergic to sulphonamides
  • Participants who have a current history of drug or alcohol abuse that, in the opinion of the investigator, may be an impediment to participant adherence to the protocol
  • Female participants who are currently pregnant or breastfeeding
  • Female participants desiring pregnancy during the next year
  • Participants who have a strong likelihood of relocating far enough to make access to the study site difficult
  • Any condition(s) or laboratory report that, in the opinion of the investigator, might put the participant at risk, or interfere with the study objectives or the participant's adherence to study requirements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02671383

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South Africa
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, Gauteng, South Africa, 2196
Sponsors and Collaborators
Willem Daniel Francois Venter
Medical Research Council, South Africa
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Willem Daniel Francois Venter, Professor, University of Witwatersrand, South Africa Identifier: NCT02671383    
Other Study ID Numbers: WRHI052
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Willem Daniel Francois Venter, University of Witwatersrand, South Africa:
Antiretroviral Agents
Viral Load
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors