Cissy Kityo
ID: UNCST-2021-R013663
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ACTIV-2/A5401: Adaptive Platform Treatment Trial for Outpatients with COVID-19
(Adapt Out COVID)
REFNo: HS1813ES
1.1 Co-Primary Objectives
1.1.1 Phases II and III: To evaluate safety of the investigational agent.
1.1.2 Phase II: To determine efficacy of the investigational agent to reduce the duration of COVID-19 symptoms through study day 28.
1.1.3 Phase II: To determine the efficacy of the investigational agent to increase the proportion of participants with nasopharyngeal (NP) SARS-CoV-2 RNA below the lower limit of quantification (LLoQ) at study days 3, 7, and 14.
1.1.4 Phase III: To determine if the investigational agent will prevent the composite endpoint of hospitalization due to any cause or death due to any cause through study day 28. Hospitalization is defined as ≥24 hours of acute care, in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19 during the COVID-19 pandemic.
1.2 Secondary Objectives
1.2.1 Phases II and III: To determine whether the investigational agent reduces a COVID-19 Severity Ranking scale based on COVID-19-associated symptom burden (severity and duration), hospitalization, and death, through study day 28.
1.2.2 Phase II and III: To determine whether the investigational agent reduces the progression of COVID-19-associated symptoms.
1.2.3 Phase II and III: To determine if the investigational agent reduces levels of SARS-CoV-2 RNA in NP swabs.
1.2.4 Phase III: To determine the efficacy of the investigational agent to increase the proportion of participants with NP SARS-CoV-2 RNA below the LLoQ at study day 3.
1.2.5 Phase II: To determine the pharmacokinetics of the investigational agent.
1.2.6 Phase II: To determine efficacy of the investigational agent to obtain pulse oximetry measurement of ≥96% through day 28.
1.2.7 Phase III: To determine if the investigational agent will prevent the composite endpoint of hospitalization due to any cause or death due to any cause through study week 72.
1.2.8 Phase III: To evaluate if the investigational agent reduces the time to sustained symptom resolution through study day 28.
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Wakiso,
Mpigi,
Mukono,
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Uganda |
2021-11-22 |
2024-11-22 |
The phase II evaluation will enroll approximately 110 participants per investigational agent (and 110 on placebo) (this includes all participants enrolled under previous protocol versions, irrespectiv |
Outpatient adults (≥18 years) with a documented positive SARS-CoV-2 molecular (nucleic acid) or antigen test from a sample collected ≤240 hours (10 days) prior to study entry and with ≤7 days of symptoms of COVID-19 at study entry, plus the presence |
The National Institute of Allergy and Infectious Diseases, Division of AIDS/NIAID/NIH/DHHS, Rockville, Maryland 20892 USA |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Francis Ssali
ID: UNCST-2021-R012134
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A Phase 2, Open-label, Single-arm, Multicentre Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Efficacy of Switching to RPV Plus Other ARVs in HIV-1-infected Children (Aged 2 to less than 12 years) who are Virologically Suppressed (TMC278HTX2002)
REFNo: HS1815ES
Primary Endpoints
• Area under the plasma concentration-time curve from the time of administration up to 24 hours post-dose of RPV, as derived from the intensive PK assessments.
• Incidence of grade 3/4 AEs, SAEs, HIV-related events (including acquired immune deficiency syndrome [AIDS]-defining illnesses and Stage-3-defining Opportunistic Illnesses in HIV Infection), and AEs leading to discontinuation of study intervention through 24 weeks of study treatment.
Secondary Endpoint
• Incidence and severity of AEs/HIV-related events and their relatedness to RPV through 24 and 48 weeks of study treatment.
• Change from baseline Movement.
• Viral genotype at the time of virologic failure through 24 and 48 weeks of study treatment.
• Treatment adherence, as assessed by the Pediatric European Network for the Treatment of AIDS (PENTA) adherence questionnaire and by study intervention accountability, through 24 and 48 weeks of study treatment.
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Wakiso, Makindye
,
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Uganda |
2021-11-22 |
2024-11-22 |
lower limit is 3 and Upper limit is 10 |
Participants (boys and girls) aged ≥2 to <12 years with a bodyweight of at least 11 kg |
Janssen Sciences Ireland Unlimited Company |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Jerome Kabakyenga Kahuma
ID: UNCST-2021-R013729
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The A-Lite vein locator: “a non-invasive assistive medical device designed to improve vein visibility among patients requiring intravenous therapy.â€
REFNo: HS1547ES
Main Objective
1. To assess the efficacy, safety and impact of using an assistive medical device to aid vein visibility among patients requiring intravenous therapy.
Specific Objectives
1. To assess the safety and efficacy of the A-Lite vein locator among 10 adults in Uganda.
2. To investigate non-inferiority by assessing the performance of the A-Lite vein locator with respect to the existing standard of care among 48 adolescents in Uganda.
3. To determine the effectiveness of using the A-Lite vein locator for improving vein visibility among 156 children requiring intravenous cannulation in Uganda.
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Kalungu, Bugonzi
Lira, Junior Quarters
Mbarara, Rwebishekye
Isingiro, Kashojwa
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Uganda |
2021-11-19 |
2024-11-19 |
214 |
Ages eligible for the study: 1 up to 30 years
Sexes eligible for the study: All
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International Development Research Centre (IDRC) – Canada and the Government of Uganda |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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ANGELLA MUSIIMENTA
ID: UNCST-2021-R013297
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My Mobile Wallet: An Intervention to Support Access to Tuberculosis Care and medication Adherence in Rural Uganda
REFNo: HS1688ES
Assess the refined My Mobile Wallet intervention for larger scale feasibility, acceptability, and impact on TB treatment adherence and clinical outcomes. We will randomize 162 newly diagnosed TB patients (1:1:1) to SMS texts + incentives Arm A, SMS texts only B, and control Arm C (standard clinic-based TB care); follow-up will be the 6 month-treatment period. Feasibility and acceptability will be assessed per above. Impact will be based on electronically monitored medication adherence (primary), as well as treatment completion, clinic attendance, cure, and mortality (secondary).,Refine the My Mobile Wallet intervention. We will adapt the intervention to address any feasibility and accessibility issues raised in R21 findings. We will then pilot test the refined version of the intervention in 10 TB patients over two months of treatment to ensure optimal functionality. ,Assess the initial feasibility and acceptability of My Mobile Wallet. Forty patients with newly diagnosed TB will use My Mobile Wallet over their 6-month course of treatment. Feasibility will be assessed by appropriate receipt of the cash transfers and SMS texts, and intervention functionality. Acceptability will be assessed using System Usability Scale [53] and interviews based on the Unified Theory of Acceptance and Use of Technology [54].,Determine the optimal design and develop My Mobile Wallet as an intervention to support TB medication adherence. Through client-centered approaches, we will iteratively conduct focus group discussions with up to 30 TB patients to develop an optimal My Mobile Wallet intervention.,
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Mbarara, Kamukuzi
Mbarara,
|
Uganda |
2021-11-19 |
2024-11-19 |
242 |
TB patients (18 and above years old) living not beyond 60 Kilometers from MRRH who are willing to participate in the study |
US National Institute of Health (Eunice Kennedy Shriver National Institute Of Child Health & Human Development of the National Institutes of Health) |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Adeodata Rukyalekere Kekitiinwa
ID: UNCST-2019-R000799
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BREATHER Plus: A randomized open-label 2-arm, 96-week trial evaluating the efficacy, safety and acceptability of short cycle (five days on, two days off) dolutegravir/tenofovir-based triple antiretroviral therapy (ART) compared to daily dolutegravir/tenofovir- based triple ART in virologically suppressed HIV-infected adolescents aged 12 to 19 years of age in sub-Saharan Africa, Version 2.0, Dated 18-Mar-2020; ISRCTN #: 85058577
REFNo: HS1822ES
Major Objective: A randomized open-label 2-arm, 96-week trial evaluating the efficacy, safety and acceptability of short cycle (five days on, two days off) dolutegravir/tenofovir-based triple antiretroviral therapy (ART) compared to daily dolutegravir/tenofovir-based triple ART in virologically suppressed HIV-infected adolescents aged 12 to 19 years of age in sub- Saharan Africa
Specific Objectives
To evaluate an innovative and contemporary ART strategy in HIV-infected adolescents to provide choice for young people facing life-long treatment. Output from this RCT will provide evidence on efficacy, safety and acceptability of a novel treatment approach in HIV-infected adolescents in sub-Saharan Africa
To evaluate the virological efficacy, safety, acceptability and Quality of Life of DTG-based Short-cycle Therapy with weekends off compared with Continuous Therapy with a DTG- based ART regimen
To optimize treatment for HIV-infected adolescents in sub-Saharan Africa
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Kampala, Mulago
Wakiso, Seguku
|
Uganda |
2021-11-15 |
2024-11-15 |
460 |
HIV-infected, non-pregnant, non-breastfeeding adolescents aged 12 to 19 years of age, virologically-suppressed for at least one year, without any history of treatment failure, on 3-drug combination antiretroviral (ART) consisting of dolutegravir with a 2- |
University College London (UCL), UK and funded by the European and Developing Countries Clinical Trials Partnership [RIA2017MC- 2005] |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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