Johan Lombaard
A5020905427- HIV/AIDS drug development and treatment
- HIV/AIDS Research and Interventions
- HIV Research and Treatment
- SARS-CoV-2 and COVID-19 Research
- Vaccine Coverage and Hesitancy
- COVID-19 Clinical Research Studies
- HIV, Drug Use, Sexual Risk
- HIV-related health complications and treatments
- Pneumocystis jirovecii pneumonia detection and treatment
- Hepatitis C virus research
- Immunotherapy and Immune Responses
- Statistical Methods in Clinical Trials
- Biochemical and Molecular Research
- Computational Drug Discovery Methods
- Ethics in Clinical Research
- Viral Infections and Outbreaks Research
- LGBTQ Health, Identity, and Policy
- vaccines and immunoinformatics approaches
- SARS-CoV-2 detection and testing
- Pediatric health and respiratory diseases
- Viral-associated cancers and disorders
- Adolescent Sexual and Reproductive Health
Preexposure prophylaxis with antiretroviral drugs has been effective in the prevention of human immunodeficiency virus (HIV) infection some trials but not others.In this randomized, double-blind, placebo-controlled trial, we assigned 2120 HIV-negative women Kenya, South Africa, and Tanzania to receive either a combination tenofovir disoproxil fumarate emtricitabine (TDF-FTC) or placebo once daily. The primary objective was assess effectiveness TDF-FTC preventing HIV acquisition evaluate...
The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants threatens progress toward control the disease 2019 (Covid-19) pandemic. In a phase 1–2 trial involving healthy adults, NVX-CoV2373 nanoparticle vaccine had an acceptable safety profile and was associated with strong neutralizing-antibody antigen-specific polyfunctional CD4+ T-cell responses. Evaluation efficacy needed in setting ongoing SARS-CoV-2 transmission.
Long-acting injectable regimens may simplify therapy for patients with human immunodeficiency virus type 1 (HIV-1) infection.We conducted a phase 3, randomized, open-label trial in which adults HIV-1 infection who had not previously received antiretroviral were given 20 weeks of daily oral induction dolutegravir-abacavir-lamivudine. Participants an RNA level less than 50 copies per milliliter after 16 randomly assigned (1:1) to continue the current or switch cabotegravir plus rilpivirine...
We aimed to assess the effectiveness of a single dose Ad26.COV2.S vaccine (Johnson & Johnson) in health-care workers South Africa during two waves African COVID-19 epidemic.
Background: Several clinical trials have demonstrated the safety and effectiveness of oral tenofovir disoproxil fumarate (TDF), with or without emtricitabine (FTC), as pre-exposure prophylaxis (PrEP) for reducing risk HIV acquisition. Adherence to study product was insufficient demonstrate FTC/TDF in 2 PrEP conducted among women (FEM-PrEP Vaginal Oral Interventions Control Epidemic study), but further analyses adherence these studies may inform demonstration projects future prevention...
There is a paucity of data on COVID-19 vaccines in people living with HIV-1, who could be at increased risk severe illness and death from COVID-19. We evaluated the safety immunogenicity Matrix-M adjuvanted recombinant spike protein nanoparticle vaccine (NVX-CoV2373; Novavax) HIV-negative HIV-1.In this randomised, observer-blinded, multicentre, placebo-controlled phase 2A/B trial South Africa, participants aged 18-84 years, without underlying were enrolled 16 sites randomly assigned (1:1) to...
FEM-PrEP was unable to demonstrate the effectiveness of oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) as pre-exposure prophylaxis for HIV prevention because low adherence. We hypothesized that one reason poor adherence perceived risk.At enrollment and at quarterly follow-up visits, we assessed participants' risk subsequent 4 weeks. used logistic regression assess factors associated with some (small, moderate, or high) risk. also robust variance estimation association between...
Oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) has been evaluated as pre-exposure prophylaxis (PrEP). We describe the accuracy of self-reported adherence to FTC/TDF and pill counts when compared drug concentrations in FEM-PrEP trial. Using plasma tenofovir (TFV) intracellular diphosphate (TFVdp) among a random sub-sample 150 participants assigned FTC/TDF, we estimated positive predictive value (PPV) four measures. also assessed factors associated with misreporting using multiple...
The phase 3 ATLAS and FLAIR studies demonstrated that maintenance with Long-Acting (LA) intramuscular cabotegravir rilpivirine is non-inferior in efficacy to current antiretroviral (CAR) oral therapy. Both utilized Patient-Reported Outcome instruments measure treatment satisfaction (HIVTSQ) acceptance (ACCEPT general domain), health status (SF-12), injection tolerability/acceptance (PIN), preference. In pooled analyses, LA-treated patients (n = 591) greater mean improvements from baseline...
ABSTRACT Background The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants threatens progress toward control the Covid-19 pandemic. Evaluation vaccine efficacy against SARS-CoV-2 is urgently needed to inform development and use. Methods In this phase 2a/b, multicenter, randomized, observer-blinded, placebo-controlled trial in South Africa, healthy human immunodeficiency virus (HIV)-negative adults (18 84 years) or medically stable people living with HIV (PLWH)...
The COVID-19 pandemic has caused millions of infections and deaths resulted in unprecedented international public health social economic crises. As SARS-CoV-2 spread across the globe its impact became evident, development safe effective vaccines a priority. Outlining processes used to establish support conduct phase 3 randomized clinical trials that led rapid emergency use authorization approval several is major significance for current future response efforts.
GSK3532795 (formerly known as BMS-955176) is a second-generation maturation inhibitor targeting specific Gag cleavage site between capsid p24 and spacer peptide 1 of HIV-1. Study 205891 (previously AI468038) investigated the efficacy, safety, dose response in treatment-naive, HIV-1-infected participants. (NCT02415595) was Phase IIb, randomized, active-controlled, double-blind, international trial. Participants were randomized 1:1:1:1 to one three arms at doses 60 mg, 120 mg or 180 once daily...
Background: Rilpivirine has shown adequate antiviral activity, consistent pharmacokinetics and safety in adults adolescents living with HIV-1. Pharmacokinetics, safety, activity of rilpivirine were assessed children, following at least 48 weeks treatment. Methods: Cohort 2 the open-label, phase PAINT study (NCT00799864) included antiretroviral-naïve children HIV-1 ≥6 to <12 years old, a viral load ≤100,000 RNA copies/mL. Participants received weight-based doses combination background...
Abstract: Biomedical HIV-prevention research is most likely to succeed when researchers actively engage with community stakeholders. To this effect, the Joint United Nations Programme on HIV/AIDS and AIDS Vaccine Advocacy Coalition developed good participatory practice guidelines for biomedical trials in 2007 updated them 2011. The Preexposure Prophylaxis Trial HIV Prevention among African Women (FEM-PrEP) clinical trial, testing once-daily Truvada as preexposure prophylaxis women at higher...
Safety of tenofovir disoproxil fumarate/emtricitabine (TDF-FTC) has been studied more extensively among HIV-infected patients than HIV-uninfected people. Using data from a pre-exposure trial – FEM-PrEP –, we determined the cumulative probabilities grade 1+ ALT, AST and creatinine 2+ phosphorus toxicities; ALT/AST toxicities by baseline hepatitis B status; change in mean creatinine, phosphorus, ALT levels controlling for TDF-FTC adherence. was randomized, blinded, placebo-controlled daily...
Abstract Given limited data on safety and effectiveness of heterologous COVID-19 vaccine boosting in lower income, high-HIV prevalence settings, we evaluated a mRNA-1273 boost after Ad26.COV2.S priming South Africa. SHERPA was single-arm, open-label, phase 3 study nested the Sisonke implementation trial 500000 healthcare workers (HCWs). participants were offered boosters between May November 2022, period circulating Omicron sub-lineages. Adverse events (AE) self-reported, co-primary...
Abstract Background Doravirine (DOR) demonstrated noninferior efficacy to darunavir plus ritonavir (DRV+r) and efavirenz (EFV) in 2 ongoing phase 3 trials: DRIVE-FORWARD (NCT02275780) DRIVE-AHEAD (NCT02403674). Methods This prespecified analysis pooled data through the first 48 weeks of from DOR groups (DOR/lamivudine [3TC]/tenofovir disoproxil fumarate [TDF] or [100 mg daily] with emtricitabine [FTC]/TDF abacavir [ABC]/3TC [n = 747]) compared DRV+r (800/100 daily) FTC/TDF ABC/3TC (n 383)...
Rilpivirine 25 mg qd yields similar exposure in adolescents and adults (Pediatric study Adolescents Investigating a New NNRTI TMC278 [PAINT] Cohort 1, Part 1). We report rilpivirine safety, efficacy, virology pharmacokinetics during 48 weeks of treatment (Cohort 2).PAINT (NCT00799864) is phase II, ongoing, open-label, single-arm trial plus 2 investigator-selected nucleoside/nucleotide reverse-transcriptase inhibitors. 1 PAINT includes treatment-naïve HIV-1-infected (≥12 to <18 years)....
Limited studies have been conducted on the safety and effectiveness of heterologous COVID-19 vaccine boosting in lower income settings, especially those with high-HIV prevalence., The Sisonke Heterologous mRNA-1273 boost after prime Ad26.COV2.S (SHERPA) trial evaluated a priming South Africa. SHERPA was single-arm, open-label, phase 3 study nested implementation 500000 healthcare workers (HCWs). participants were offered boosters between May November 2022, when Omicron sub-lineages...
COVID-19 remains a global public health issue and an improved understanding of vaccine performance in immunocompromised individuals, including people living with HIV (PLWH), is needed. Initial data from the present study's pre-crossover/booster phase were previously reported. This 2a/b clinical trial South Africa (2019nCoV-501/NCT04533399) revisits 1:1 randomly assigned HIV-negative adults (18-84 years) medically stable PLWH (18-64 who received two NVX-CoV2373 doses (5 μg recombinant Spike...