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  1. Adaption of an ongoing clinical trial to quickly respond to gaps in changing international recommendations: the experience of D2EFT
    Papot E, Jacoby S, Arlinda D, Avihingsanon A, Azwa I, Borok M, et al.
    HIV Res Clin Pract, 2022 Jul 19;23(1):37-46.
    PMID: 35938597
    A rapidly changing landscape of antiretrovirals and their procurement at scale has permitted the evaluation of new optimised second-line antiretroviral therapy (ART) in low- and middle-income countries. D2EFT is an open-label randomised controlled non-inferiority phase IIIB/IV trial in people living with HIV-1 (PWH) whose first-line non-nucleoside reverse transcriptase inhibitor (NNRTI)-based ART is failing. At inception, it compared a standard of care of boosted darunavir with two nucleos(t)ide reverse transcriptase inhibitors (NRTIs) to the novel NRTI-sparing regimen of boosted darunavir with dolutegravir. Implemented in 2017, participating sites were across Africa, Asia and Latin America. Around the time of implementation, the World Health Organization updated its treatment guidelines and recommended scaling up tenofovir disoproxil fumarate-lamivudine-dolutegravir (TLD). This situation pushed D2EFT investigators to consider the impact of the roll-out of TLD on the D2EFT research question. The protocol team agreed it was important to study TLD in second-line when an NNRTI regimen was failing, and focused on options to expedite the work by studying the question within the existing trial and network. All key issues (statistical, programmatic and financial) were reviewed to assess the benefits and risks of adding a third arm to the ongoing study, as opposed to developing a new randomised clinical trial with the same control arm and within the same network. The development of a new trial was deemed to be longer than adding a third arm, and to create a challenging situation with two competing clinical trials at the same sites which would slow down recruitment and impair both trials. On the other hand, adding a third arm would be demanding in terms of operationalisation, increased sample size and statistical biases to control. The optimal strategy was deemed to be the addition of a third arm, arriving retrospectively at a simplified multi-arm multi-stage clinical trial design to achieve statistical validity. The D2EFT study maintains additional value in a quickly evolving second-line ART strategy allowed by the progress in global access to ART.
  2. SARS-CoV-2 cross-sectional serosurvey across three HIV-1 therapeutic clinical trials in Africa
    Papot E, Tovar-Sanchez T, Woods J, Thaurignac G, Eriobu N, Borok M, et al.
    AIDS, 2024 Nov 22.
    PMID: 39576151 DOI: 10.1097/QAD.0000000000004068
    OBJECTIVE: Data on the impact of COVID-19 in people living with HIV (PWH) are lacking in resource-constrained settings. We utilised existingrandomised clinical trials (RCTs) on antiretroviral therapies (ART) in HIV-1 infection to conduct a SARS-CoV-2 serosurvey, between January and March 2021, while characterising participants' features.

    DESIGN: Cross-sectional serosurvey.

    METHODS: Demographic characteristics, medical history and a serum sample were collected from consenting PWH. Samples were analysed centrally for immunoglobulin G antibodies to recombinant nucleocapsid and spike proteins derived from SARS-CoV-2 using a Luminex based assay.

    RESULTS: The 549participants recruited in 9 sites across Africa had a median age of 40 years (IQR [34-45]); 63.0% (346) were female. All were on ART; 81.8% (449) had an HIV-1 viral load <50 copies/mL, with CD4 count median at 478/mm3 (IQR [320-677]). None had received vaccination against SARS-CoV-2. Forty participants (7.3%) had a prior SARS-CoV-2 PCR testing, of whom 10 were positive (1.8%). Crude SARS-CoV-2 seroprevalence was 36.2% (; 95%CI [32.2-40.4]). In the explorative multivariable analysis, comparison of the characteristics of PWH with a positive SARS-CoV-2 serology with those with a negative or indeterminate serology: PWH with a body mass index (BMI)≥30 kg/m2 were more likely to have a positive serology than those with a BMI≤25 (aOR = 2.39 [1.48-3.86], p 

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