Judith Tikabibamu

Expediting a UNIVERSAL first-line regimen of a dolutegravir–emtricitabine–tenofovir alafenamide fixed-dose ratio for children living with HIV older than 4 weeks: a 24-week, open-label, single-arm, phase 1–2, pharmacokinetic, safety, and antiviral activity trial

Anne E M Kamphuis, Nicolas Salvadori, Hilda Angela Mujuru, Mutsawashe Bwakura-Dangarembizi et autres

nl, th, Zimbabwe, Ouganda, it (code pays fourni par la source)

Switch to injectable cabotegravir–rilpivirine given every 8 weeks in adolescents living with HIV with virological suppression in sub-Saharan Africa (LATA): a randomised, open-label, multicentre, 96-week non-inferiority trial

Mutsa Bwakura-Dangarembizi, Elizabeth Chappell, Cissy Kityo, Diana Louis Anena et autres

BACKGROUND: Adolescents living with HIV have poorer treatment outcomes than other age groups and might benefit from long-acting-injectable (LAI) antiretroviral therapy (ART). We evaluated efficacy and safety of LAI cabotegravir-rilpivirine compared with daily oral ART in adolescents living with HIV with virological …

Zimbabwe, gb, Ouganda, Kenya, Afrique du Sud, it, nl (code pays fourni par la source)

Efficacy and safety of short-cycle, dolutegravir-based antiretroviral therapy in adolescents living with HIV (BREATHER Plus): a multicentre, open-label, randomised, parallel, two-arm, non-inferiority trial

Adeodata Kekitiinwa, Angus Jennings, Mutsa Bwakura-Dangarembizi, Cissy Kityo et autres

BACKGROUND: Short-cycle antiretroviral therapy (ART), comprising 5 days on and 2 days off treatment, offers the potential for ART-free weekends, reduced toxicity, and improved quality of life for adolescents living with HIV, who typically have worse treatment outcomes than other age groups. …

Ouganda, gb, Zimbabwe, Kenya, Afrique du Sud, it, ca, nl (code pays fourni par la source)

Weight gain, body composition, and metabolic parameters of dolutegravir-based antiretroviral therapy versus standard of care in children and adolescents: an ancillary analysis of the ODYSSEY trial

Anna Turkova, Ellen White, Avy Violari, Hilda A Mujuru et autres

BACKGROUND: ODYSSEY trial showed superior efficacy of dolutegravir-based antiretroviral therapy (ART) versus then-current, non-dolutegravir standard of care over 96 weeks in children and adolescents living with HIV. The aim of this ancillary analysis was to compare anthropometric and body composition outcomes, including …

gb, Afrique du Sud, Zimbabwe, Ouganda, th, de, fr, it, es (code pays fourni par la source)

Trial design and enrolment characteristics of LATA (Long-Acting Treatment in Adolescents): A randomised, open-label, non-inferiority, 96-week trial evaluating the virological efficacy, safety, acceptability and quality-of-life of the dual long-acting injectable regimen cabotegravir/ rilpivirine compared to daily oral therapy in virologically suppressed adolescents with HIV-1 infection, aged 12 to <20 years, in Sub-Saharan Africa

Diana Anena, Elizabeth Chappell, Rashidah Nazzinda, Cecilia Kiilu et autres

BACKGROUND: Alternatives to daily oral antiretroviral therapy (ART) are important for adolescents with HIV (AHIV) to improve adherence and outcomes. Long-Acting-injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) has demonstrated excellent efficacy and safety and strong patient preference in adults. METHODS: LATA is an ongoing randomised, …

Ouganda, gb, Kenya, Zimbabwe, Afrique du Sud, it, nl (code pays fourni par la source)

Once-daily dolutegravir/lamivudine fixed-dose formulations in children living with HIV: a pharmacokinetic and safety sub-study nested in the open-label, multicentre, randomised, non-inferiority D3/PENTA 21 trial

Lisanne A. H. Bevers, Gabriela Toledo, Muzamil Kisekka, Isabelle Déprez et autres

Background Two-drug regimen dolutegravir/lamivudine (DTG/3TC) is recommended as an alternative to standard three-drug regimens in adult treatment guidelines. This nested pharmacokinetic sub-study within the D3/Penta 21 randomised trial (#NCT04337450) assessed DTG and 3TC concentrations and safety in virologically-suppressed children, switching to once-daily …

nl, gb, Ouganda, ca, Afrique du Sud, it (code pays fourni par la source)

Neuropsychiatric manifestations and sleep disturbances with dolutegravir-based antiretroviral therapy versus standard of care in children and adolescents: a secondary analysis of the ODYSSEY trial

Anna Turkova, Ellen White, Adeodata Kekitiinwa, Vivian Mumbiro et autres

BACKGROUND: Cohort studies in adults with HIV showed that dolutegravir was associated with neuropsychiatric adverse events and sleep problems, yet data are scarce in children and adolescents. We aimed to evaluate neuropsychiatric manifestations in children and adolescents treated with dolutegravir-based treatment versus …

gb, Ouganda, Zimbabwe, Afrique du Sud, th, de, es, fr, it (code pays fourni par la source)

Nucleoside/nucleotide reverse transcriptase inhibitor sparing regimen with once daily integrase inhibitor plus boosted darunavir is non-inferior to standard of care in virologically-suppressed children and adolescents living with HIV – Week 48 results of the randomised SMILE Penta-17-ANRS 152 clinical trial

Alexandra Compagnucci, Man K. Chan, Yacine Saïdi, Tim R. Cressey et autres

Background Integrase inhibitor (INSTI) with boosted darunavir (DRV/r), a regimen with a high-resistance barrier, avoiding NRTI toxicities, might be a switching option in children living with HIV (CLWHIV). Methods SMILE is a randomised non-inferiority trial evaluating safety and antiviral efficacy of once-daily …

fr, gb, th, it, Ouganda, Afrique du Sud, ua, ar, pa, mx, es, ch, pt, de (code pays fourni par la source)

Once-daily dolutegravir-based antiretroviral therapy in infants and children living with HIV from age 4 weeks: results from the below 14 kg cohort in the randomised ODYSSEY trial

Pauline Amuge, Abbas Lugemwa, Ben Wynne, Hilda Mujuru et autres

BACKGROUND: Young children living with HIV have few treatment options. We aimed to assess the efficacy and safety of dolutegravir-based antiretroviral therapy (ART) in children weighing between 3 kg and less than 14 kg. METHODS: ODYSSEY is an open-label, randomised, non-inferiority trial …

Ouganda, gb, Zimbabwe, Afrique du Sud, it, es (code pays fourni par la source)

Dolutegravir twice-daily dosing in children with HIV-associated tuberculosis: a pharmacokinetic and safety study within the open-label, multicentre, randomised, non-inferiority ODYSSEY trial

Anna Turkova, Hylke Waalewijn, Man K. Chan, Pauline Bollen et autres

BACKGROUND: Children with HIV-associated tuberculosis (TB) have few antiretroviral therapy (ART) options. We aimed to evaluate the safety and pharmacokinetics of dolutegravir twice-daily dosing in children receiving rifampicin for HIV-associated TB. METHODS: on the first substudy day. All children within ODYSSEY with …

gb, nl, Zimbabwe, Ouganda, Afrique du Sud, th, us (code pays fourni par la source)