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HIV InfectionsPhase 3DRVNCT02671383

Evaluation of Low-dose Darunavir in a Switch Study

A Phase 3 study testing Darunavir and Lopinavir in people with HIV Infections, run by Willem Daniel Francois Venter at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
Darunavir and Lopinavir
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteSouth Africa
Study dates
30 Jun 2016to 16 May 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Africa1 site

  • Charlotte Maxeke Johannesburg Academic Hospital

    Johannesburg, Gauteng, 2196

Other trials in South Africa

About this study

Official title: A Randomised, Open Label Switch Study Comparing Darunavir/Ritonavir 400mg/100mg Daily With Lopinavir/Ritonavir 800mg/200mg Daily, in HIV-positive Participants

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.

Read the 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 clinicaltrial.gov.

Conditions
HIV Infections
Being tested
Darunavir, Lopinavir
Keywords
Antiretroviral Agents, Treatment, Viral Load
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DarunavirDrug

    Also called Boosted darunavir (DRV/r)

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

  • LopinavirDrug

    Also called Boosted lopinavir (LVP/r)

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

Study groups in NCT02671383
Study groupRoleWhat they receive
DarunavirActive comparatorDarunavir/Ritonavir 400/100mg once daily
Receives: Drug: Darunavir
LopinavirActive comparatorLopinavir/Ritonavir 400/100mg twice daily
Receives: Drug: Lopinavir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with undetectable HIV-1 RNA levels

    Measured: Week 48

  2. Number of participants with certain adverse events related to the treatment

    Measured: Week 48

Secondary outcomes (1)

  1. Time to virologic failure

    Measured: Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2016 (estimated)
  2. Study start30 Jun 2016
  3. Primary completion16 May 2018
  4. Study completion16 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02671383
Sponsor's protocol ID
WRHI052
Acronym
DRV
Status last verified
Jun 2018
First submitted
28 Jan 2016
Last updated
26 Jun 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 32996891

  • 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.

    PubMed 31202690

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Darunavir and Lopinavir in people with HIV Infections, run by Willem Daniel Francois Venter at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with undetectable HIV-1 RNA levels (time frame: Week 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02671383, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018; AzTrials last refreshed its copy on 1 Nov 2026.

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