Official Title
COVID-19 in People Living With HIV: Evaluation of Risk Factors and Outcomes in Resource-limited Settings. A Pooled Substudy of ADVANCE, D²EFT, DolPHIN2 and NAMSAL
Brief Summary

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.

Detailed Description

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.

Completed
HIV-infection/Aids
Coronavirus Infection
Eligibility Criteria

Inclusion Criteria:

- ≥ 18 years old.

- Either: i) Meet local testing criteria for COVID-19, or present with symptoms that in
the opinion of the investigator are consistent with COVID-19 and do not have an
alternative explanation, or have tested elsewhere and found positive for COVID-19; OR
ii) Agree for serology testing for SARS-CoV2, regardless of history of COVID-19.

- Have signed the informed consent of one of the parent study.

- Give informed consent to the COHIVE substudy.

Exclusion Criteria:

- Refuse to participate in the COHIVE substudy.

- Any condition which would place the participant at risk if they participated.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Argentina
Brazil
Cameroon
India
Malaysia
Nigeria
South Africa
Thailand
Uganda
Zimbabwe
Locations

Hospital G de Agudos JM Ramos Mejia
Buenos Aires, Ciudad De Buenos Aires, Argentina

Laboratório de Pesquisa Clinica Em Hiv/Aids - Instituto Nacional de Infectologia - Fiocruz
Rio de Janeiro, 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, India

Univerity of Malaya Medical Centre
Kuala Lumpur, Malaysia

Institute of Human Virology, Nigeria (IHVN)
Abuja, Nigeria

Desmond Tutu HIV Foundation
Cape Town, South Africa

Perinatal HIV Research Unit (PHRU)
Johannesburg, South Africa

Clinical HIV Research Unit (CHRU), Wits Health Consotium (Pty) Ltd
Johannesburg, South Africa

Ezintsha
Parktown, South Africa

HIV-NAT (The HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Centre
Bangkok, Thailand

Infectious Diseases Institute
Kampala, Uganda

University of Zimbabwe Clinical Research Centre
Harare, Zimbabwe

Kirby Institute
NCT Number
Keywords
Covid-19
SARS-CoV-2
HIV
MeSH Terms
Infections
Communicable Diseases
COVID-19
HIV Infections
Coronavirus Infections
Acquired Immunodeficiency Syndrome