D2EFT
Tahapan Penelitian : Recruit
Sponsor:
University of New South Wales, The Kirby Institute University of NSW, New South Wales, Australia
Mitra Pelaksana:
National Institute of Health Research and Development (NIHRD), Indonesia
No Registry
INA-HETTL12
Tanggal Input Registry : 13-04-2020
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 24-01-2020 |
| Outcome Primer | The proportion of participants in each arm whose pVL is |
| Outcome Skunder | Virological • Proportion with pVL |
| Descriptive Information | |
| Judul Penelitian Popular | D2EFT |
| Judul Penelitian Ilmiah | 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 |
| Jenis Penelitian | Bioequivalence study |
| Intervensi | Yes: Dolutegravir, Darunavir, Ritonavir |
| Jumlah Subyek Penelitian | 40 |
| Recruitment Information | |
| Eligibility Criteria | 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 consentExclusion Criteria: 1. The following laboratory variables: a) absolute neutrophil count (ANC) |
| Administrative Information | |
| Nomor Persetujuan Etik | LB.02.01/2/KE.195/2019 |
| Nomor Persetujuan Material Transfer Agreement | |
| Nomor Persetujuan Pelaksanaan Uji Klinik | |
| Other Study ID Numbers | D2EFT |
| Contact Person | Dr. Muhammad Karyana, MPH, Ph: +622142879189, Email. mkaryana@ina-respond.net |