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| Name | Class |
|---|---|
| University of Witwatersrand, South Africa | OTHER |
| University of Liverpool | OTHER |
| Université Montpellier | OTHER |
| UNITAID |
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COHIVE is an observational cohort nested in four antiretroviral therapy research studies (ADVANCE - NCT03122262; D²EFT - NCT03017872; DolPHIN2 - NCT03249181 and NAMSAL-ANRS12313 - NCT02777229). COHIVE will include participants who are possible COVID-19 cases with symptoms or confirmed COVID-19 cases, and participants who agree to have a serology testing for SARS-CoV-2 regardless of COVID-19 history.
COHIVE is an observational cohort study nested within four parent open label randomised clinical trials of first- and second-line antiretroviral therapies (ADVANCE - NCT03122262; D²EFT - NCT03017872; DolPHIN2 - NCT03249181 and NAMSAL-ANRS12313 - NCT02777229). COHIVE objective is to study the occurrence and outcomes of COVID-19 in people living with HIV across a variety of clinical settings. Taken together, these pivotal trials provide an established population and encompass a range of HIV therapies, HIV populations, and geographic regions to capture the full spectrum of these global public health emergency as it pertains to people living with HIV.
The sample will include participants who are possible symptomatic or confirmed COVID-19 cases, and participants who agree to enrol in the SARS-CoV-2 seroprevalence cohort (regardless of SARS-CoV-2 infection). Approximately 2,500 participants are enrolled in these 4 studies.
Enrolment into COHIVE substudy is voluntary and optional for participants in ADVANCE, D²EFT, DolPHIN2 and NAMSAL studies. Parameters relevant to COHIVE substudy including demographics, arm of randomised ART, medical and HIV history, immunological and virological results, adverse events at required time points will be collected as part of parent studies. Substudy specific assessments performed at baseline include optional sample collection for SARS-CoV-2 RT-PCR and serology; for the possible symptomatic or confirmed COVID-19 cases, the management of the patients, diagnostic test results, and outcomes, will be collected.
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical features of symptomatic COVID-19 in people living with HIV (PLWH) | To characterise the clinical features of symptomatic COVID-19 in PLWH (cardio-respiratory and other clinical signs or symptoms), described overall and by HIV and comorbid disease factors including pregnancy status. | At baseline |
| Clinical outcomes of symptomatic COVID-19 in PLWH | To characterise the clinical outcomes of symptomatic COVID-19 in PLWH, assessing the outcomes of patients including the percentage of patients who are fully recovered, required hospitalisation, developed severe illness (ICU admission or equivalent) or died. | At Day 28 |
| Clinical outcomes of symptomatic COVID-19 in PLWH | To characterise the clinical outcomes of symptomatic COVID-19 in PLWH, assessing the outcomes of patients including the percentage of patients who are fully recovered, required hospitalisation, developed severe illness (ICU admission or equivalent) or died. | At Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Seroprevalence of COVID-19 in all parent study participants | To determine seroprevalence of COVID-19 in all parent study participants regardless of COVID-19 history. | Through study completion, an average of one year |
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Inclusion Criteria:
Exclusion Criteria:
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The substudy will be proposed to all the sites participating in ADVANCE, D²EFT, DolPHIN2 and NAMSAL studies. This substudy will enrol eligible patients with i) confirmed or suspected infection with SARS-CoV-2 and ii) any participants of the 4 parent studies who accept to enrol in the seroprevalence cohort during a scheduled parent study protocol visit following control of the epidemic in country.
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| Name | Affiliation | Role |
|---|---|---|
| Alexandra Calmy, MD, PhD | University Hospital, Geneva | Principal Investigator |
| Eric Delaporte, MD, PhD | IRD, Inserm, University of Montpellier | Principal Investigator |
| Saye Khoo, MD, PhD | University of Liverpool | Principal Investigator |
| Emmanuelle Papot, MD | Kirby Institute | Principal Investigator |
| Mark Polizzotto, MD, PhD | Kirby Institute | Study Chair |
| Francois WD Venter, MD | Wits Reproductive Health and HIV Institute | Principal Investigator |
| Joana Woods, MD | Wits Reproductive Health and HIV Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital G de Agudos JM Ramos Mejia | Buenos Aires | Buenos Aires F.D. | C1221ADC | Argentina | ||
| Laboratório de Pesquisa Clinica Em Hiv/Aids - Instituto Nacional de Infectologia - Fiocruz |
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| OTHER |
| ViiV Healthcare | INDUSTRY |
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| Rio de Janeiro |
| 21040-360 |
| Brazil |
| Central Hospital of Yaoundé | Yaoundé | Cameroon |
| Cité Verte Hospital | Yaoundé | Cameroon |
| Hôpital Militaire de Région N°1 | Yaoundé | Cameroon |
| CART CRS, VHS Hospital | Chennai | Tamil Nadu | 600113 | India |
| Univerity of Malaya Medical Centre | Kuala Lumpur | Malaysia |
| Institute of Human Virology, Nigeria (IHVN) | Abuja | 9396 | Nigeria |
| Desmond Tutu HIV Foundation | Cape Town | 7925 | South Africa |
| Perinatal HIV Research Unit (PHRU) | Johannesburg | 2013 | South Africa |
| Clinical HIV Research Unit (CHRU), Wits Health Consotium (Pty) Ltd | Johannesburg | 2041 | South Africa |
| Ezintsha | Parktown | 2193 | South Africa |
| HIV-NAT (The HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Centre | Bangkok | 10330 | Thailand |
| Infectious Diseases Institute | Kampala | Uganda |
| University of Zimbabwe Clinical Research Centre | Harare | 263 | Zimbabwe |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| 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 |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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