Evaluation of Low-dose Darunavir in a Switch Study

NCT02671383 | Completed Phase 3 DMC

• 1 other identifier: WRHI052
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

Antiretroviral Agents; Treatment; Viral Load

Outcome Measures

Primary Outcomes (2)

• Number of participants with undetectable HIV-1 RNA levels

  Week 48

• Number of participants with certain adverse events related to the treatment

  Week 48

Secondary Outcomes (1)

• Time to virologic failure

  Week 48

Other Outcomes (3)

• Lipids measure

  Baseline, Week 24 and 48

• Fasting glucose measure

  Baseline and Week 48

• Creatinine clearance measure

  Baseline, Week 12, 24, and 48

Study Arms (2)

Darunavir

ACTIVE COMPARATOR

Darunavir/Ritonavir 400/100mg once daily

Drug: Darunavir

Lopinavir

ACTIVE COMPARATOR

Lopinavir/Ritonavir 400/100mg twice daily

Drug: Lopinavir

Interventions

Darunavir DRUG

Darunavir/ritonavir 400/100mg (DRV/r) once daily plus nucleoside/nucleotide reverse transcriptase inhibitors.

Also known as: Boosted darunavir (DRV/r)

Darunavir

Lopinavir DRUG

Lopinavir/ritonavir 400/100mg (LPV/r) twice daily plus nucleoside/nucleotide reverse transcriptase inhibitors.

Also known as: Boosted lopinavir (LVP/r)

Lopinavir

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Willem Daniel Francois Venter: lead
• Medical Research Council, South Africa: collaborator

Study Sites (1)

Charlotte Maxeke Johannesburg Academic Hospital

Johannesburg, Gauteng, 2196, South Africa

Location

Related Publications (2)

• Draaijer M, Lalla-Edward ST, Venter WDF, Vos A. Phone Calls to Retain Research Participants and Determinants of Reachability in an African Setting: Observational Study. JMIR Form Res. 2020 Sep 30;4(9):e19138. doi: 10.2196/19138.

  PMID: 32996891 DERIVED

• Venter WDF, Moorhouse M, Sokhela S, Serenata C, Akpomiemie G, Qavi A, Mashabane N, Arulappan N, Sim JW, Sinxadi PZ, Wiesner L, Maharaj E, Wallis C, Boyles T, Ripin D, Stacey S, Chitauri G, Hill A. Low-dose ritonavir-boosted darunavir once daily versus ritonavir-boosted lopinavir for participants with less than 50 HIV RNA copies per mL (WRHI 052): a randomised, open-label, phase 3, non-inferiority trial. Lancet HIV. 2019 Jul;6(7):e428-e437. doi: 10.1016/S2352-3018(19)30081-5. Epub 2019 Jun 12.

  PMID: 31202690 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Darunavir; Lopinavir

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

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: February 2, 2016
• Study Start: June 30, 2016
• Primary Completion: May 16, 2018
• Study Completion: May 16, 2018
• Last Updated: June 26, 2018

Record last verified: 2018-06

Locations

ZA (1)