HIVINAPROACTIVENCT03663920
HIV Infection and Risk Related Coinfections/Comorbidities in Indonesia
An observational study of HIV, run by Ina-Respond at 19 sites in Indonesia.
Trial summary
INA-PROACTIVE is a multicenter, prospective, observational cohort study of HIV positive antiretroviral-naïve and treatment-experienced individuals. No investigational treatment or intervention will be used by this study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV
- How many people
- 4,336 participants
- Where
- 19 sitesIndonesia
- Study dates
- 9 Jan 2018to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This is a prospective descriptive study that aims to estimate the characteristics, including among death cases, of people living with HIV in Indonesia. The study population will include people living with HIV at any age, any sex/gender, any HIV-affected key populations, whether ART-naïve or treatment-experienced in Indonesia. To get an estimation with 95% confidence interval (95% CI) that represents the true value in population. We calculated the minimum death cases need to be observed using the proportion of female HIV patients among death cases in Indonesia in 2016 (31%) and case fatality rate for HIV patients in Indonesia, 2016 (1.11%). The minimum number of death to be observed and HIV patients to be enrolled
Who may be able to join
- HIV positive by the Standard of Care.
- Documented informed consent for participants' ≥18 years old or informed consent by parents/legally accepted representative (LAR) or assent for minor participants prior to study procedures.
- Willing to comply with the study procedures.
- Agrees to the collection and storage of specimens for use in future research on immune function, pathogenesis, and/or genetics/genomics of HIV and opportunistic infections. (The participant may decline participation in genetic or genomics research and will still be eligible for the study).
Who cannot join
- Plans to move away to an area where the participant will not be able to complete the study visits in 3 years.
- Is currently imprisoned.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Indonesia19 sites
Site 670 - RSUD Dr. Zainoel Abidin
Banda Aceh, 24415
Site 510: University of Padjajaran/ Dr. Hasan Sadikin Hospital
Bandung, West Java, 40161
Site 630: M. Ansari Saleh Hospital
Banjarmasin, South Kalimantan, 70125
Site 650: Budi Kemuliaan Hospital
Batam, Riau Islands
Site 520: University of Udayana/Sanglah Hospital
Denpasar, Bali, 80114
Site 530: University of Indonesia/ Dr. Cipto Mangunkusumo Hospital
Jakarta, DKI Jakarta, 10430
Site 540: Penyakit Infeksi Sulianti Saroso Hospital
Jakarta, DKI Jakarta, 14340
Site 590: Persahabatan Hospital
Jakarta, DKI Jakarta, 14340
Site 640: St. Carolus Hospital
Jakarta, 10440
Site 690 - RSUD Abepura
Jayapura, Special Region of Papua, 99351
Site 550: University of Hassanudin/ Dr. Wahidin Sudirohusodo Hospital
Makassar, 90245
Site 700 - RSUD Dr.TC Hillers
Maumere, East Nusa Tenggara, 86113
Site 600 : Adam Malik Hospital
Medan, North Sumatra, 20136
Site 680 - RSUD dr Soedarso
Pontianak, West Kalimantan, 78111
Site 660 RSUD Abdul Wahab Sjahranie
Samarinda, East Kalimantan, 75123
Site 560: University of Diponegoro/ Dr. Kariadi Hospital
Semarang, Central of Java, 50244
Site 570: University of Airlangga/ Dr. Soetomo Hospital
Surabaya, East of Java, 60286
Site 610 : RSU Kabupaten Tangerang
Tangerang, West Java, 15111
Site 580: University of Gadjah Mada/ Dr. Sardjito Hospital
Yogyakarta, 55284
About this study
Official title: A Prospective Observational Cohort Study on HIV Infection and Risk Related Coinfections/Comorbidities in Indonesia
INA-PROACTIVE is a multicenter, prospective, observational cohort study of HIV positive antiretroviral-naïve and treatment-experienced individuals. No investigational treatment or intervention will be used by this study. All participants will be managed according to the Indonesian HIV/AIDS Treatment Guideline and/or the Standard of Care (SoC) in local clinical setting, with the addition of rapid HIV viral load, CD4 cell count and syphilis testing.
Read the detailed description
This study will accept participants meeting the eligibility criteria and data will be collected at baseline visit and 6-monthly regular follow up visits for 3 years (at month 6, 12, 18, 24, 30, and 36). The study will allow a ± 3-month window period for each scheduled regular follow up visit to minimize loss to follow up. Additional follow up data may be collected between regular follow up visits on certain participants who meet the additional follow up criteria.
During each visit, data collection will include socio-demographics, family history, past and current medical history, clinical assessments, laboratory and/or other supporting diagnosis examination. Blood specimens from each study visits will be collected for future research on immune function, pathogenesis, and genetics or genomics of HIV and risk related coinfections/comorbidities. The stored specimens will be investigated during the study and/or after the study completion.
Based on the highest number of HIV cases in hospitals from the National HIV/AIDS Control Program (MoHRI, 2016), 33 hospitals were identified as the proposed study sites (Appendix B). Ten hospitals are established INA-RESPOND's study sites. They are Dr. Cipto Mangunkusumo Hospital, Prof. Dr. Sulianti Saroso Infectious Diseases Hospital, and Persahabatan Hospital in Jakarta; Dr. Hasan Sadikin Hospital, Bandung; Dr. Kariadi Hospital, Semarang; Dr. Sardjito Hospital, Yogyakarta; Dr. Soetomo Hospital, Surabaya; Sanglah Hospital, Denpasar; Dr. Wahidin Sudirohusodo Hospital, Makassar; and Kab. Tangerang Hospital, Banten.
Ten additional new study sites will be selected from the list (Appendix B) and the INA-RESPOND team will conduct site assessments to determine their willingness and readiness to be INA-PROACTIVE study sites. If site activation is lagging, other hospitals not on the list can also be assessed as a potential study sites.
The total 20 study sites will be activated gradually based on their readiness within 2 years (12 sites on year-1 and additional 8 sites on year-2). It is expected that the additional new sites will expand the network, increase participants' recruitment, and will be able to represent Indonesian situation.
- Conditions
- HIV
- Keywords
- Viral Load, CD4, Mortality, Disease Progression
- Medical subject headings
- Disease Progression
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of participants achieving viral suppression (HIV RNA Viral Load <1000 copies/mL) in Indonesia.
Incidence of participants achieving viral suppression with HIV RNA Viral Load <1000 copies/mL.
Measured: From date of enrollment until the date of 36 months of follow-up study visit, lost to follow-up or death, whichever came first, assessed up to 3 years
Secondary outcomes (6)
Proportion of participants with HIV RNA Viral Load <1000 copies/mL at baseline and every six-monthly follow-up visit.
Proportion of participants with HIV RNA Viral Load <1000 copies/mL at baseline and every six-monthly follow-up visit as virological outcomes
Measured: From date of enrollment until the date of 36 months of follow-up study visit, lost to follow-up or death, whichever came first, assessed up to 3 years
Mean change in CD4+ cell count from baseline and every six-monthly follow-up visit.
Evaluate the immunologic response by the CD4 measurement from baseline (Mean change in CD4+ cell count) and every six-monthly follow-up visit as immunological outcomes
Measured: From date of enrollment until the date of 36 months of follow-up study visit, lost to follow-up or death, whichever came first, assessed up to 3 years
Proportion of AIDS defining illnesses at baseline and every six-monthly follow-up visit.
Proportion of AIDS defining illnesses from baseline and every six-monthly follow-up visit as disease progression outcomes
Measured: From date of enrollment until the date of 36 months of follow-up study visit, lost to follow-up or death, whichever came first, assessed up to 3 years
Proportion of serious non-AIDS disease at baseline and every six-monthly follow-up visit.
Proportion of serious non-AIDS disease from baseline and every six-monthly follow-up visit as disease progression outcomes
Measured: From date of enrollment until the date of 36 months of follow-up study visit, lost to follow-up or death, whichever came first, assessed up to 3 years
Incidence of AIDS-related deaths at baseline and every six-monthly follow-up visit.
Incidence of AIDS-related deaths at baseline and every six-monthly follow-up visit as the mortality outcomes
Measured: From date of enrollment until the date of 36 months of follow-up study visit, lost to follow-up or death, whichever came first, assessed up to 3 years
Incidence of non-AIDS-related deaths at baseline and every six-monthly follow-up visit.
Incidence of non-AIDS-related deaths at baseline and every six-monthly follow-up visit as the mortality outcomes
Measured: From date of enrollment until the date of 36 months of follow-up study visit, lost to follow-up or death, whichever came first, assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start9 Jan 2018
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ina-Respond
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. dr. Tuti Parwati Merati, Sp.PD.KPTI, Principal investigator, Faculty of Medicine Udayana University-Sanglah Hospital, Denpasar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663920
- Sponsor's protocol ID
- INA104
- Other IDs
- U1111-1263-2484
- Acronym
- INAPROACTIVE
- Status last verified
- Nov 2023
- First submitted
- 4 Jan 2018
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Merati TP, Yunihastuti E, Wisaksana R, Kurniati N, Arlinda D, Karyana M, Susanto NH, Lokida D, Kosasih H, Diana A, Bang LE, Setiyaningrum M, Amin DM, Eppy E, Cahyawati WASN, Danudirgo EW, Darmaja IMG, Farhanah N, Gunawan CA, Hadi U, Jamil KF, Katu S, Kembaren T, Kosa IGR, Norosingomurti DL, Purnama A, Laksanawati IS, Rusli A, Somia IKA, Subronto YW, Toruan IL, Ridzon R, Liang CJ, Neal AT, Chen RY; INA-PROACTIVE Study Group. 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.
PubMed 39833697
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Cohort Study on HIV Infection and Risk Related Coinfections/Comorbidities in Indonesia
- ClinicalTrials.gov ID
- NCT03663920
- Acronym / sponsor ID
- INAPROACTIVE / INA104
- Conditions
- HIV
- Keywords
- Viral Load, CD4, Mortality, Disease Progression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,336 participants (actual)
- Lead sponsor
- Ina-RespondUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 10 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
INA-PROACTIVE is a multicenter, prospective, observational cohort study of HIV positive antiretroviral-naïve and treatment-experienced individuals. No investigational treatment or intervention will be used by this study. All participants will be managed according to the Indonesian HIV/AIDS Treatment Guideline and/or the Standard of Care (SoC) in local clinical setting, with the addition of rapid HIV viral load, CD4 cell count and syphilis testing.
Detailed description
This study will accept participants meeting the eligibility criteria and data will be collected at baseline visit and 6-monthly regular follow up visits for 3 years (at month 6, 12, 18, 24, 30, and 36). The study will allow a ± 3-month window period for each scheduled regular follow up visit to minimize loss to follow up. Additional follow up data may be collected between regular follow up visits on certain participants who meet the additional follow up criteria.
During each visit, data collection will include socio-demographics, family history, past and current medical history, clinical assessments, laboratory and/or other supporting diagnosis examination. Blood specimens from each study visits will be collected for future research on immune function, pathogenesis, and genetics or genomics of HIV and risk related coinfections/comorbidities. The stored specimens will be investigated during the study and/or after the study completion.
Based on the highest number of HIV cases in hospitals from the National HIV/AIDS Control Program (MoHRI, 2016), 33 hospitals were identified as the proposed study sites (Appendix B). Ten hospitals are established INA-RESPOND's study sites. They are Dr. Cipto Mangunkusumo Hospital, Prof. Dr. Sulianti Saroso Infectious Diseases Hospital, and Persahabatan Hospital in Jakarta; Dr. Hasan Sadikin Hospital, Bandung; Dr. Kariadi Hospital, Semarang; Dr. Sardjito Hospital, Yogyakarta; Dr. Soetomo Hospital, Surabaya; Sanglah Hospital, Denpasar; Dr. Wahidin Sudirohusodo Hospital, Makassar; and Kab. Tangerang Hospital, Banten.
Ten additional new study sites will be selected from the list (Appendix B) and the INA-RESPOND team will conduct site assessments to determine their willingness and readiness to be INA-PROACTIVE study sites. If site activation is lagging, other hospitals not on the list can also be assessed as a potential study sites.
The total 20 study sites will be activated gradually based on their readiness within 2 years (12 sites on year-1 and additional 8 sites on year-2). It is expected that the additional new sites will expand the network, increase participants' recruitment, and will be able to represent Indonesian situation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is a prospective descriptive study that aims to estimate the characteristics, including among death cases, of people living with HIV in Indonesia. The study population will include people living with HIV at any age, any sex/gender, any HIV-affected key populations, whether ART-naïve or treatment-experienced in Indonesia. To get an estimation with 95% confidence interval (95% CI) that represents the true value in population. We calculated the minimum death cases need to be observed using the proportion of female HIV patients among death cases in Indonesia in 2016 (31%) and case fatality rate for HIV patients in Indonesia, 2016 (1.11%). The minimum number of death to be observed and HIV patients to be enrolled
Key inclusion criteria (4 listed)
- HIV positive by the Standard of Care.
- Documented informed consent for participants' ≥18 years old or informed consent by parents/legally accepted representative (LAR) or assent for minor participants prior to study procedures.
- Willing to comply with the study procedures.
- Agrees to the collection and storage of specimens for use in future research on immune function, pathogenesis, and/or genetics/genomics of HIV and opportunistic infections. (The participant may decline participation in genetic or genomics research and will still be eligible for the study).
Key exclusion criteria (2 listed)
- Plans to move away to an area where the participant will not be able to complete the study visits in 3 years.
- Is currently imprisoned.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of participants achieving viral suppression (HIV RNA Viral Load <1000 copies/mL) in Indonesia.
Time frame: From date of enrollment until the date of 36 months of follow-up study visit, lost to follow-up or death, whichever came first, assessed up to 3 years
Incidence of participants achieving viral suppression with HIV RNA Viral Load <1000 copies/mL.
6 secondary outcomes
Proportion of participants with HIV RNA Viral Load <1000 copies/mL at baseline and every six-monthly follow-up visit.
Time frame: From date of enrollment until the date of 36 months of follow-up study visit, lost to follow-up or death, whichever came first, assessed up to 3 years
Mean change in CD4+ cell count from baseline and every six-monthly follow-up visit.
Time frame: From date of enrollment until the date of 36 months of follow-up study visit, lost to follow-up or death, whichever came first, assessed up to 3 years
Proportion of AIDS defining illnesses at baseline and every six-monthly follow-up visit.
Time frame: From date of enrollment until the date of 36 months of follow-up study visit, lost to follow-up or death, whichever came first, assessed up to 3 years
Proportion of serious non-AIDS disease at baseline and every six-monthly follow-up visit.
Time frame: From date of enrollment until the date of 36 months of follow-up study visit, lost to follow-up or death, whichever came first, assessed up to 3 years
Incidence of AIDS-related deaths at baseline and every six-monthly follow-up visit.
Time frame: From date of enrollment until the date of 36 months of follow-up study visit, lost to follow-up or death, whichever came first, assessed up to 3 years
Incidence of non-AIDS-related deaths at baseline and every six-monthly follow-up visit.
Time frame: From date of enrollment until the date of 36 months of follow-up study visit, lost to follow-up or death, whichever came first, assessed up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Derived from this study: PubMed 39833697Merati TP, Yunihastuti E, Wisaksana R, Kurniati N, Arlinda D, Karyana M, Susanto NH, Lokida D, Kosasih H, Diana A, Bang LE, Setiyaningrum M, Amin DM, Eppy E, Cahyawati WASN, Danudirgo EW, Darmaja IMG, Farhanah N, Gunawan CA, Hadi U, Jamil KF, Katu S, Kembaren T, Kosa IGR, Norosingomurti DL, Purnama A, Laksanawati IS, Rusli A, Somia IKA, Subronto YW, Toruan IL, Ridzon R, Liang CJ, Neal AT, Chen RY; INA-PROACTIVE Study Group. 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Dr. dr. Tuti Parwati Merati, Sp.PD.KPTI principal investigator
Faculty of Medicine Udayana University-Sanglah Hospital, Denpasar
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Ina-Respond at 19 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of participants achieving viral suppression (HIV RNA Viral Load <1000 copies/mL) in Indonesia. (time frame: From date of enrollment until the date of 36 months of follow-up study visit, lost to follow-up or death, whichever came first, assessed up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03663920, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.