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HIV Infection and Risk Related Coinfections/Comorbidities in Indonesia (INAPROACTIVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663920
Recruitment Status : Active, not recruiting
First Posted : September 10, 2018
Last Update Posted : July 14, 2020
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Ina-Respond

Brief 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.

Condition or disease
HIV

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.

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Study Type : Observational
Actual Enrollment : 4336 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Cohort Study on HIV Infection and Risk Related Coinfections/Comorbidities in Indonesia
Actual Study Start Date : January 9, 2018
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    Proportion of participants with HIV RNA Viral Load <1000 copies/mL at baseline and every six-monthly follow-up visit as virological outcomes

  2. 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 ]
    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

  3. 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 AIDS defining illnesses from baseline and every six-monthly follow-up visit as disease progression outcomes

  4. 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 ]
    Proportion of serious non-AIDS disease from baseline and every six-monthly follow-up visit as disease progression outcomes

  5. 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 AIDS-related deaths at baseline and every six-monthly follow-up visit as the mortality outcomes

  6. 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 ]
    Incidence of non-AIDS-related deaths at baseline and every six-monthly follow-up visit as the mortality outcomes


Biospecimen Retention:   Samples With DNA
Subjects or subject's parent must be willing to allow storage plasma and buffy coat at baseline visit and plasma at every follow up visit. All samples will be stored at the INA-RESPOND Reference laboratory and at each site


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663920


Locations
Show Show 19 study locations
Sponsors and Collaborators
Ina-Respond
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Prof. Dr. dr. Tuti Parwati Merati, Sp.PD.KPTI Faculty of Medicine Udayana University-Sanglah Hospital, Denpasar
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Responsible Party: Ina-Respond
ClinicalTrials.gov Identifier: NCT03663920    
Other Study ID Numbers: INA104
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ina-Respond:
Viral Load
CD4
Mortality
Disease Progression
Additional relevant MeSH terms:
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Coinfection
HIV Infections
Infection
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Parasitic Diseases