HIV Infection and Risk Related Coinfections/Comorbidities in Indonesia

HIV Clinical Trial

— INAPROACTIVE  

Official title:

A Prospective Observational Cohort Study on HIV Infection and Risk Related Coinfections/Comorbidities in Indonesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03663920
• Other study ID #: INA104
• Secondary ID: U1111-1263-2484
• Status: Completed
• Start date: January 9, 2018
• Est. completion date: September 30, 2023

Study information

• Verified date: November 2023
• Source: Ina-Respond
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4336
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria:

1. HIV positive by the Standard of Care.

2. 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.

3. Willing to comply with the study procedures.

4. 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).

Exclusion criteria:

1. Plans to move away to an area where the participant will not be able to complete the study visits in 3 years.

2. Is currently imprisoned.

Related Conditions & MeSH terms

• Coinfection
• HIV
• HIV Infections

Locations

Country	Name	City	State
Indonesia	Site 670 - RSUD Dr. Zainoel Abidin	Banda Aceh
Indonesia	Site 510: University of Padjajaran/ Dr. Hasan Sadikin Hospital	Bandung	West Java
Indonesia	Site 630: M. Ansari Saleh Hospital	Banjarmasin	South Kalimantan
Indonesia	Site 650: Budi Kemuliaan Hospital	Batam	Riau Islands
Indonesia	Site 520: University of Udayana/Sanglah Hospital	Denpasar	Bali
Indonesia	Site 530: University of Indonesia/ Dr. Cipto Mangunkusumo Hospital	Jakarta	DKI Jakarta
Indonesia	Site 540: Penyakit Infeksi Sulianti Saroso Hospital	Jakarta	DKI Jakarta
Indonesia	Site 590: Persahabatan Hospital	Jakarta	DKI Jakarta
Indonesia	Site 640: St. Carolus Hospital	Jakarta
Indonesia	Site 690 - RSUD Abepura	Jayapura	Papua
Indonesia	Site 550: University of Hassanudin/ Dr. Wahidin Sudirohusodo Hospital	Makassar
Indonesia	Site 700 - RSUD Dr.TC Hillers	Maumere	East Nusa Tenggara
Indonesia	Site 600 : Adam Malik Hospital	Medan	North Sumatra
Indonesia	Site 680 - RSUD dr Soedarso	Pontianak	West Kalimantan
Indonesia	Site 660 RSUD Abdul Wahab Sjahranie	Samarinda	East Kalimantan
Indonesia	Site 560: University of Diponegoro/ Dr. Kariadi Hospital	Semarang	Central Of Java
Indonesia	Site 570: University of Airlangga/ Dr. Soetomo Hospital	Surabaya	East Of Java
Indonesia	Site 610 : RSU Kabupaten Tangerang	Tangerang	West Java
Indonesia	Site 580: University of Gadjah Mada/ Dr. Sardjito Hospital	Yogyakarta

Sponsors (2)

Lead Sponsor	Collaborator
Ina-Respond	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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	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	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	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	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	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	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	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	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	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	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	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