NCT03602690

Brief Summary

The study aims to evaluate the virological effectiveness of a third-line regimen combining dolutegravir (DTG), ritonavir-boosted darunavir (DRV/r) and optimized NRTI in Cambodian HIV-infected adults, who failed a protease inhibitors (PI)-based second-line regimen despite 3 months of boosted adherence counseling (BAC).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2018

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 27, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 4, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2022

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

3.5 years

First QC Date

July 6, 2018

Last Update Submit

August 25, 2021

Conditions

HIV/AIDS

Keywords

Third-line regimenDolutegravirDarunavirCambodia

Outcome Measures

Primary Outcomes (1)

  • Virological effectiveness at 6 months

    Proportion of patients with plasma HIV-1 RNA \< 40 copies/mL by FDA Snapshot analysis

    Month 6

Secondary Outcomes (6)

  • Virological effectiveness at 12 months

    Month 12

  • Incidence of adverse events (safety)

    Month 12

  • Tolerance

    Month 12

  • Adherence to treatment strategy

    Month 12

  • Plasmatic drug concentrations

    Month 1

  • +1 more secondary outcomes

Study Arms (1)

Dolutegravir + Darunavir/ritonavir + optimized NRTI

EXPERIMENTAL

All patients will receive ART regimen every day including: Dolutegravir 50mg once daily Darunavir/ritonavir 600/100 twice daily Optimized NRTI recycling with lamivudine and one other NRTI (zidovudine or tenofovir or abacavir)

Drug: Dolutegravir + Darunavir/ritonavir + optimized NRTI

Interventions

Dolutegravir + Darunavir/ritonavir + optimized NRTIDRUG

Dolutegravir 50mg once daily Darunavir/ritonavir 600/100 twice daily Optimized NRTI recycling with lamivudine and one other NRTI (zidovudine or tenofovir or abacavir)

Dolutegravir + Darunavir/ritonavir + optimized NRTI

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Documented HIV-1 infection
  • Failing a NNRTI-based first-line regimen
  • Failing a PI-based second-line regimen after 3 months of adherence boosting (HIV RNA \> 1000 copies/mL)
  • HIV strain intermediate or fully resistant to ATV/r OR sensitive to ATV but both resistant to AZT, ABC and TDF
  • For women of childbearing age: acceptance to use effective contraceptive methods

You may not qualify if:

  • History of antiretroviral treatment including darunavir and integrase inhibitor
  • Active pregnancy \< 12 weeks of amenorrhea and desire of pregnancy during the duration of the study
  • Advanced cirrhosis (Child-Pugh score B or C)
  • Creatinine clearance \< 50 ml/mn
  • Any concomitant medical condition that, according to the clinical site investigator would contraindicate participation in the study
  • Concurrent participation in any other clinical study without written agreement of the two study teams

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NCHADS

Phnom Penh, Cambodia

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

dolutegravirDarunavirRitonavir

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsCarbamatesAcids, AcyclicCarboxylic AcidsSulfonesSulfur CompoundsFuransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiazolesAzoles

Central Study Contacts

Phearavin Pheng

CONTACT

+85512578726phearavinpheng@uhs.edu.kh

Olivier Segeral

CONTACT

+85512479313oliseg@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2018

First Posted

July 27, 2018

Study Start

October 4, 2018

Primary Completion

April 11, 2022

Study Completion

April 11, 2022

Last Updated

August 26, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)