D2EFT

Tahapan Penelitian : Rekrut
Sponsor:
Mitra Pelaksana:
National Institute of Health Research and Development (NIHRD), Indonesia
No Registry
INA-HETTL12
Tanggal Input Registry : 13-04-2020

24-01-2020
The proportion of participants in each arm whose pVL is
Virological • Proportion with pVL
 
D2EFT
A phase IIIB/IV randomised open-label trial to compare dolutegravir with pharmaco-enhanced darunavir versus dolutegravir with predetermined nuclosides versus recommended standard of care antiregroviral regimens in patients with HIV-1 who have failed recommended first line therapy
Eksperimental
Yes: Dolutegravir, Darunavir, Ritonavir
40
 

Inclusion Criteria:

1. HIV-1 positive by licensed diagnostic test 2. Aged ≥18 years of age (or minimum age as determined by local regulations or as legal requirements dictate) 3. Failed first-line non-nucleoside reverse transcriptase inhibitor (NNRTI) + 2NRTI combination therapy according to virological criteria, defined as at least two consecutive (≥7 days apart) pVL results >500 copies/mL after a minimum period of exposure to continuous NNRTI + 2NRTI first-line therapy of 24 weeks (only the second pVL result needs to be within 45 days of randomisation) 4. For women of child-bearing potential, willingness to use appropriate contraception 5. Able to provide written informed consent

Exclusion Criteria:

1. The following laboratory variables: a) absolute neutrophil count (ANC)
 
LB.02.01/2/KE.195/2019
N/A
1. Site 8881: RSUPN dr. Cipto Mangunkusumo approval number: B-RG.01.06.3.32.321.08.19.2939
D2EFT
Dr. Muhammad Karyana, MPH, Ph: +622142879189, Email. mkaryana@ina-respond.net