ClinicalTrials.gov: NCT03663920
Collaborator: NIAID, NIH
Status: Completed
INA-PROACTIVE
A Prospective Observational Cohort Study on HIV Infection And Risk Related Coinfections/Comorbidities In Indonesia - INA104 (PROACTIVE)
https://clinicaltrials.gov/study/NCT03663920
The PROACTIVE study was a multicenter, prospective, observational cohort study of 4,336 (4,147 adults, 189 children) HIV-positive individuals enrolled between January 2018 and June 2020. Participants were observed every six months for up to three years as they received medical care according to the Indonesian HIV/AIDS Treatment Guidelines and/or the standard of care at their local clinic. Additional study-specific testing included CD4+ cell count, HIV plasma viral load, hepatitis B surface antigen, hepatitis C antibody, and syphilis antibody. During each study visit, blood samples, extensive demographic information, and clinical data were collected, including medical histories, routine laboratory results, and antiretroviral treatment regimens.
Most adults were between 30 and 39 years old at enrollment (42.6%), were suspected of acquiring HIV by heterosexual transmission (53.3%), had undetectable viral loads (72.4%), and had taken antiretroviral regimens for more than 12 months (66.1%). Limited targeted sequencing of specimens identified CRF01_AE as the dominant circulating strain, as well as a variety of drug resistance mutations, including tenofovir-associated K65R mutations.
Colloborated Sites:
- 510 – RSUP Dr. Hasan Sadikin, Bandung
- 520 – RSUP Prof. dr. I.G.N.G. Ngoerah, Denpasar, Bali
- 530 – RSUPN Dr. Cipto Mangunkusumo, Jakarta
- 540 – Pusat Infeksi Nasional RSPI Sulianti Saroso, Jakarta
- 550 – RSUP Dr. Wahidin Sudirohusodo, Makassar
- 560 – RSUP Dr. Kariadi, Semarang
- 570 – RSUD Dr. Soetomo, Surabaya
- 580 – RSUP Dr. Sardjito, Yogyakarta
- 590 – RSUP Persahabatan, Jakarta
- 600 – RSUP H. Adam Malik, Medan
- 610 – RSUD Kab. Tangerang, Tangerang
- 630 – RSUD dr. H. Moch Ansari Saleh, Banjarmasin
- 640 – RS St. Carolus, Jakarta
- 650 – RS Budi Kemuliaan, Batam
- 660 – RSUD H. A. Wahab Sjahranie, Samarinda
- 670 – RSUD Dr. Zainoel Abidin, Aceh
- 680 – RSUD Soedarso, Pontianak
- 690 – RSUD Abepura, Papua
- 700 – RSUD TC Hillers, NTT
Associated Publications:
- A prospective observational cohort study of HIV infection in Indonesia: baseline characteristics and one-year mortality. BMC Infect Dis. 2025 Jan 20;25(1):87. doi: 10.1186/s12879-024-10354-8. PMID: 39833697.
- Development of a multiassay algorithm (MAA) to identify recent HIV infection in newly diagnosed individuals in Indonesia. iScience. 2023 Sep 21;26(10):107986. doi: 10.1016/j.isci.2023.107986. PMID: 37854696.
- Annual trends and risk factors of late presentation of HIV at 19 referral hospitals in Indonesia: findings from the INA-PROACTIVE cohort; The Lancet Regional Health South East Asia; Vol 46, 100742, March 2026
Associated Biorepository
| Specimen type | Visit type | Viral Load (copies/ml) | ||||
| Total | <50 | 50 – <1,000 | 1000-10,000 | >10,000 | ||
| Plasma | M0 | 4,335 | 3,092 | 359 | 197 | 687 |
| M6 | 4,022 | 3,425 | 232 | 55 | 310 | |
| M12 | 3,864 | 3,403 | 165 | 55 | 241 | |
| M18 | 3,734 | 3,327 | 140 | 55 | 212 | |
| M24 | 3,625 | 3,273 | 112 | 40 | 200 | |
| M30 | 3,507 | 3,191 | 93 | 44 | 179 | |
| M36 | 3,495 | 3,183 | 101 | 39 | 172 | |
| Buffy Coat | M0 | 4,276 | 3,049 | 352 | 193 | 682 |
| Specimen type | Visit type | CD4+ T cell count (cells/μL) | |||
| Total | <200 | 200-349 | ≥350 | ||
| Plasma | M0 | 3,776 | 948 | 1,064 | 1,764 |
| M6 | 3,989 | 739 | 1,100 | 2,150 | |
| M12 | 3,849 | 517 | 1,085 | 2,247 | |
| M18 | 3,720 | 406 | 1,022 | 2,292 | |
| M24 | 3,608 | 364 | 992 | 2,252 | |
| M30 | 3,491 | 310 | 937 | 2,244 | |
| M36 | 3,479 | 298 | 868 | 2,313 | |
| Buffy Coat | M0 | 3,722 | 939 | 1,043 | 1,740 |
| Identified Pathogen Concurrent with HIV-1 | Specimen Type | Total | |
| Plasma | Buffy Coat | ||
| Hepatitis B Surface Antigen | 406 | 405 | 811 |
| Hepatitis C Total Antibody | 370 | 365 | 735 |
| Syphilis Total Antibody | 944 | 927 | 1,871 |
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