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| ID | Type | Description | Link |
|---|---|---|---|
| 5UM1AI068632-19 | U.S. NIH Grant/Contract | View source | |
| HHSN275201800001I | Other Grant/Funding Number | Eunice Kennedy Shriver National Institute of Child Health and Human Development |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| National Institute of Mental Health (NIMH) |
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IMPAACT 2028 is an observational prospective study to characterize a cohort of early treated children who may participate in future research related to HIV remission or cure. Up to approximately 250 participants will be in the study for approximately seven years. No intervention is provided in the study.
This is an observational prospective cohort study characterizing and establishing a biorepository of early treated children who may participate in future research related to HIV remission or cure. Early treatment is defined as treatment with at least three ARV agents from at least two classes of ART initiated within 12 weeks of birth. Within the overall study population, for descriptive and analysis purposes, children who initiated treatment within 48 hours of birth will be classified as having received very early treatment. A subset of children will have received bNAbs as part of their treatment regimens.
Up to approximately 250 children living with HIV who received early treatment in IMPAACT network studies or other research studies sponsored by the US National Institutes of Health (NIH) will be enrolled and followed semi-annually for up to seven years. Clinical, virologic, and immunologic evaluations will be performed semi-annually at each study visit, and specimens will be collected for the study's biorepository for future investigations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Children living with perinatally-acquired HIV who received early treatment in IMPAACT network studies or other research studies sponsored by the United States National Institutes of Health. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cohort 1 | Other | No intervention provided in this study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcome Measures - Weight measured in kg | Median and interquartile range; to characterize long-term clinical profile | At enrollment, at participant study completion (up until 7 years) |
| Clinical Outcome Measures - Height measured in cm | Median and interquartile range; to characterize long-term clinical profile | At enrollment, at participant study completion (up until 7 years) |
| Clinical Outcome Measures - Weight-for-height Z score | Median and interquartile range, % of participants with Z scores corresponding to mild, moderate, or severe malnutrition | At enrollment, at participant study completion (up until 7 years) |
| Clinical Outcome Measures - Head circumference measured in cm | Median and interquartile range; to characterize long-term clinical profile | At birth, 24 months of age |
| Clinical Outcome Measures - Head circumference-for-age Z score | Median and interquartile range; to characterize long-term clinical profile | At birth, 24 months of age |
| Clinical Outcome Measures - Cumulative incidence of WHO clinical Stage 3 or Stage 4 conditions | % of patients with outcome; to characterize long-term clinical profile | At enrollment, at participant study completion (up until 7 years) |
| Clinical Outcome Measures - Cumulative incidence of medical conditions that required hospitalization, resulted in persistent or significant disability or incapacity, were life threatening, or resulted in death |
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Inclusion Criteria:
Exclusion Criteria:
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Up to approximately 250 children living with HIV who received early treatment in IMPAACT network studies or other research studies sponsored by the US National Institutes of Health (NIH)
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| Name | Affiliation | Role |
|---|---|---|
| Shaun Barnabas, MD, PhD | University of Stellenbosch | Study Chair |
| Samantha Fry, MD, MMed | University of Stellenbosch | Study Chair |
| Julia Rosebush, DO, FAAP | University of Chicago | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| David Geffen School of Medicine at UCLA (CRS 5112) | Los Angeles | California | 90095 | United States | ||
| University of Colorado (5052) |
Individual participant data that underlie results in the publication, after deidentification.
Beginning 3 months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Feb 10, 2023 |
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The following specimens will be collected: HIV-1 RNA PCR, HIV-1 DNA ddPCR, CD4+ and CD8+ cell counts and percentages, HIV-1 antibody, Serum, plasma, and peripheral blood mononuclear cell (PBMC) storage, ARV resistance testing if clinically indicated. If child is three years of age or older, collect nasopharyngeal and rectal swabs for storage.
% of patients with outcome; to characterize long-term clinical profile |
| At enrollment, at participant study completion (up until 7 years) |
| Clinical Outcome Measures - Cumulative incidence of other medical conditions of interest | % of patients with outcome; to characterize long-term clinical profile | At enrollment, at participant study completion (up until 7 years) |
| Clinical Outcome Measures - Cumulative incidence of mortality | % of patients with outcome; to characterize long-term clinical profile | At study participant completion (up until 7 years) |
| Immunologic Outcome Measures - CD4+ cell counts and percentages | Median and interquartile range; to characterize long-term immunologic profile | At enrollment, at participant study completion (up until 7 years) |
| Immunologic Outcome Measures - CD8+ cell counts and percentages | Median and interquartile range; to characterize long-term immunologic profile | At enrollment, at participant study completion (up until 7 years) |
| Immunologic Outcome Measures - HIV-1 antibody status | % of participants with negative serostatus | At enrollment, at participant study completion (up until 7 years) |
| Virologic Outcome Measures - HIV-1 RNA in plasma | % of participants with HIV-1 RNA below the limit of detection of the assay among participants with quantifiable HIV-1 RNA, median and interquartile range | At enrollment, at participant study completion (up until 7 years) |
| Virologic Outcome Measures - HIV-1 DNA concentration in PBMCs | % of participants with HIV-1 DNA below the limit of detection of the assay among participants with quantifiable HIV-1 DNA, median and interquartile range | At enrollment, at participant study completion (up until 7 years) |
| Virologic Outcome Measures - HIV-1 ARV resistance mutations | % of participants with resistance mutations | At enrollment, at participant study completion (up until 7 years) |
| Aurora |
| Colorado |
| 80045 |
| United States |
| 5055, South Florida CDTC Fort Lauderdale Clinical Research Site | Fort Lauderdale | Florida | 33316 | United States |
| Univ of Miami Pediatric/Perinatal HIV/AIDS (5127) | Miami | Florida | 33136 | United States |
| 5030, Emory University School of Medicine Clinical Research Site | Atlanta | Georgia | 30322 | United States |
| 5128, Texas Children's Hospital Clinical Research Site | Houston | Texas | 77030 | United States |
| Gaborone CRS 12701 | Gaborone | Botswana |
| Molepolole Prevention/Treatment Trials CRS 12702 | Molepolole | Botswana |
| School of Medicine, University of Minas Gerais - FUNDEP (5073) | Belo Horizonte | Brazil |
| 5071, Instituto de Puericultura e Pediatria Martagao Gesteira Clinical Research Site | Rio de Janeiro | Brazil |
| Hospital dos Servidores Rio de Janeiro | Rio de Janeiro | Brazil |
| Hospital Geral De Nova Igaucu (5097) | Rio de Janeiro | Brazil |
| Ribeirao Preto Medical School, University of Sao Paulo (5074) | São Paulo | Brazil |
| Les Centres GHESKIO (30022) | Port-au-Prince | Haiti |
| 5121, Kenya Medical Research Institute/Walter Reed Project Clinical Research Center Kericho Clinical Research Site | Kericho | Kenya |
| College of Med. JHU CRS (30301) | Blantyre | Malawi |
| University of North Carolina Lilongwe (12001) | Lilongwe | Malawi |
| Soweto IMPAACT CRS (8052) | Johannesburg | Gauteng | South Africa |
| 30300, Umlazi Clinical Research Site | Durban | South Africa |
| 8051, Wits RHI Shandukani Research Centre Clinical Research Site | Johannesburg | South Africa |
| Family Clinical Research Unit (FAM-CRU) CRS (8950) | Tygerberg Hills | South Africa |
| Kilimanjaro Christian Medical Centre (5118) | Moshi | Tanzania |
| Siriraj Hospital Mahidol University CRS (5115) | Bangkok | Ratchathewi | 10700 | Thailand |
| Chiang Rai Regional Hospital (5116) | Chiang Rai | Thailand |
| 31798, Baylor-Uganda Clinical Research Site | Kampala | Uganda |
| Seke North CRS 30306 | Chitungwiza | Zimbabwe |
| St. Mary's CRS 30303 | Chitungwiza | Zimbabwe |
| Harare Family Care (31890) | Harare | Zimbabwe |
| Jan 12, 2026 |
| Prot_ICF_000.pdf |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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