Dolutegravir and Darunavir Evaluation in Adults Failing Therapy

PHASE4UnknownINTERVENTIONAL
Enrollment

831

Participants

Timeline

Start Date

November 23, 2017

Primary Completion Date

November 11, 2022

Study Completion Date

October 31, 2023

Conditions
HIV Infections
Interventions
DRUG

NRTIs

"In SOC arm, choice of NRTIs determined by clinician, guided by either genotypic resistance testing or use of a protocol-specified algorithm for N(t)RTI selection.~In D2N arm, NRTIs are predetermined."

DRUG

Dolutegravir

50mg tablet by mouth once daily for 96 weeks.

DRUG

Darunavir

800mg tablet by mouth once daily for 96 weeks.

DRUG

Ritonavir

100mg tablet by mouth once daily for 96 weeks.

Trial Locations (28)

1765

Hospital Dr Diego Paroissien, Isidro Casanova

1864

Perinatal HIV Research Unit (PHRU), Chris Hani Baragwanath Hospital, Soweto

1900

Hospital Interzonal de Agudos San Juan de Dios, La Plata

2041

Clinical HIV Research Unit (CHRU), Wits Health Consotium (Pty) Ltd, Johannesburg

7925

Desmond Tutu HIV Foundation, Cape Town

9396

Institute of Human Virology, Nigeria (IHVN), Abuja

10320

Dr. Cipto Mangunkusumo Hospital, Jakarta

10330

HIV-NAT (The HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Centre, Bangkok

10450

Hospital Pulau Pinang, George Town

11000

Bamrasnaradura Infectious Diseases Institute, Nonthaburi

14080

Instituto Nacional de Ciencias Medicas y Nutriciòn Salvador Zubiran, Mexico City

37000

Morales Vargas Centro de Investigacion SC, León

40002

Srinagarind Hospital, Khon Kaen University, Khon Kaen

44280

Hospital Civil de Guadalajara, Guadalajara

55284

Dr Sardjito Hospital, Yogyakarta

57000

Chiangrai Prachanukroh Hospital, Chiang Rai

59100

University of Malaya Medical Centre, Kuala Lumpur

60285

Dr. Soetomo Hospital, Surabaya

90241

RSUP Dr. Wahidin Sudirohusodo, Makassar

110010

ASISTENCIA Cientifica De Alta Complejidad S.A.S., Bogotá

600113

CART CRS, VHS Hospital, Chennai

8360159

Hospital San Borja-Arriaran, Santiago

C1221ADC

Hospital G de Agudos JM Ramos Mejia, Buenos Aires

S2000PBJ

CAICI, Rosario

21040-360

Laboratório de Pesquisa Clinica Em Hiv/Aids - Instituto Nacional de Infectologia - Fiocruz, Rio de Janeiro

BP:5845

Centre de traitementambulatoire de Donka ( Hopital de jour), Conakry

Unknown

University of Sciences, Techniques and Technologies of Mali, University Clinical Research Center (UCRC), Bamako

+263

University of Zimbabwe Clinical Research Centre, Harare

Sponsors
All Listed Sponsors
collaborator

UNITAID

OTHER

collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

National Health and Medical Research Council, Australia

OTHER

collaborator

ViiV Healthcare

INDUSTRY

collaborator

Janssen Pharmaceutica

INDUSTRY

lead

Kirby Institute

OTHER_GOV

NCT03017872 - Dolutegravir and Darunavir Evaluation in Adults Failing Therapy | Biotech Hunter | Biotech Hunter