Bruce Kirenga J
ID: UNCST-2019-R001460
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A multiple arm, multiple stage (MAMS), phase 2B/C, open label, randomized, controlled platform trial to evaluate experimental arms including an increased dose of rifampicin, an optimized dose of pyrazinamide, moxifloxacin and sutezolid, in adult subjects with newly diagnosed, smear-positive pulmonary tuberculosis
REFNo: HS2644ES
Primary Efficacy Objective:
Rifampicin- containing experimental arms (arms 1,2)
To evaluate whether one or more of two experimental regimens based on
optimized dose rifampicin, optimized dose of pyrazinamide, and moxifloxacin
given for 12, respectively 17 weeks, are superior to standard treatment given for
26 weeks, as assessed by time to sputum culture conversion to negative in liquid
media.
Sutezolid-containing experimental arm (arm 4)
To evaluate whether the efficacy of an experimental regimen composed of
sutezolid, delamanid, bedaquiline, and moxifloxacin given for 17 weeks is
superior to standard treatment given for 26 weeks, as assessed by time to
sputum culture conversion to negative in liquid media.
Secondary Objectives This study’s secondary objectives are:
Efficacy
To assess treatment efficacy based on proportion of patients with relapse
free outcome at 12 months after randomization.
To assess treatment efficacy based on the rate of decline of bacterial load
measured by the Molecular Bacterial Load Assay
To rank the relative efficacy of the experimental four-drug combinations
for the treatment of pulmonary tuberculosis within the first twelve weeks
of treatment, and select the most efficient experimental treatment
regimen or regimens for further development.
Safety and Tolerability
To assess the frequency, severity, and type of adverse events (AEs), and AErelated
treatment discontinuations.
Pharmacokinetics
To describe the pharmacokinetics of the drugs and doses used, and to assess
possible relationships between pharmacokinetic parameters of the various drugs and between pharmacokinetic parameters and participant characteristics.
Pharmacodynamics To describe relationships between pharmacokinetic parameters on the one hand and efficacy and safety endpoints on the other hand.
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Kampala, Kawempe
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Uganda |
2023-04-11 15:27:11 |
2026-04-11 |
360 Adults |
A total of up to 360 adult (≥ 18 years of age) participants will be enrolled.
In case of a high number of dropouts or non‐evaluable participants, it may be
necessary to recruit more participants into the study.
Also, if the stage 2 starts later than stage 1, it will be necessary to increase the
number of control arm participants to achieve a 1:1 ratio of concomitantly
recruited control and arm 4 participants (see sample size considerations).
Both males and females regardless of tribe as long as an ICF of that particular language spoken by the participant is available, will be enrolled. |
LMU Klinikum Marchioninistr. 15, 81377 Munich Germany |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Brenda Kakayi Catherine
ID: UNCST-2022-R008787
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Insulin-like Growth Factor/Growth Hormone Levels and Stunting in HIV Exposed Uninfected Children from the 1077BF/P1084s study (CHASE: Changes in IGF/Hormone Axis and Stunting in HIV-Exposed uninfected children.
REFNo: HS2686ES
1. To investigate IGF-1, IGFBP-1, and IGFBP-3 as predictors of growth faltering/stunting in the first 2 years of life in HEU children
2. To describe the concentrations of hormonal growth factors in infants in relation to infant growth percentile at birth, 26 weeks, and 74 weeks of age.
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Uganda |
2023-04-03 20:41:44 |
2026-04-03 |
Samples from approximately 154 participants from the P1084s study |
Samples of approximately 154 P1084s HEU children with serum specimens available at birth, week 26, and week 74 will have assays done on stored specimens for IGF-1, IGFBP-1, and IGFBP-3 at these time points. The 154 participants will be randomly selected from the 268 participants from Uganda, Malawi and South Africa that were enrolled in the study. The samples for use will be from both male and female participants. |
DAIDS-IMPAACT Network |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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JOSELYN RWEBEMBERA
ID: UNCST-2021-R013915
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Intramuscular vs. Enteral Penicillin Prophylaxis to Prevent Progression of Latent Rheumatic Heart Disease: A non-inferiority randomized trial. (GOALIE)
REFNo: HS2659ES
Primary Objective:
To compare the proportion of children aged 5-17 years with latent RHD receiving oral penicillin prophylaxis who progress to worse valvular disease at 2-years compared to children who receive IM penicillin prophylaxis.
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Lira, Adyel
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Uganda |
2023-03-24 2:23:26 |
2026-03-24 |
1004 |
Age group = 5-17
Sex not specified.
Tribe not specified. |
National Institute of Health |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Victoria Ndyanabangi
ID: UNCST-2021-R012645
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IMPAACT 2036: Phase I/II Study of the Safety, Tolerability,Acceptability, and Pharmacokinetics of Oral and Long-ActingInjectable Cabotegravir and Rilpivirine in Virologically SuppressedChildren Living with HIV-1, Two to Less Than 12 Years of Age, DAIDSStudy ID #38932 IND # 138754
REFNo: HS2688ES
To propose the weight band dosing of oral cabotegravir (CAB) + oral rilpivirine (RPV)followed by long-acting injectable CAB (CAB LA) + long-acting injectable RPV (RPV LA)in children living with HIV-1, and to describe participant choice and experience with theregimen with or without an oral lead-in period.
To describe the repeat-dose pharmacokinetics of CAB + RPV (oral and injectable)through Week 24
To assess the safety of the oral lead-in of CAB + RPV, and the safety of CAB + RPV (oraland injectable) through Week 24
To assess the safety of CAB + RPV (oral and injectable) through Weeks 48 and 72
To describe the repeat-dose pharmacokinetics of injectable CAB LA + RPV LA throughWeeks 48 and 72
To assess the maintenance of viral suppression of CAB + RPV (oral and injectable)through Weeks 24, 48, and 72
To evaluate the tolerability and acceptability of injectable CAB LA + RPV LA throughWeeks 24, 48, and 72
To describe HIV-1 genotypes and phenotypes for children who experience virologicfailure during study treatment
To assess immunologic activity of CAB + RPV (oral and injectable) through Weeks 24,48, and 72
To describe tolerability and acceptability of 48 weeks of CAB + RPV (oral and injectable)and 44 weeks of CAB LA + RPV LA (injectable only)
To describe the safety and repeat-dose pharmacokinetics of 48 weeks of CAB + RPV(oral and injectable) or 44 weeks of CAB LA + RPV LA (injectable only)
To describe the maintenance of viral suppression and immunologic activity of 48 weeks ofCAB + RPV (oral and injectable) or 44 weeks of CAB LA + RPV LA (injectable only)
To describe HIV-1 genotypes and phenotypes for children who experience virologicfailure during 48 weeks of CAB + RPV (oral and injectable) or during 44 weeks of CABLA + RPV LA (injectable only)
To characterize long-term safety and washout PK through 48 weeks after permanentdiscontinuation of injectable CAB LA + RPV LAV LA
To characterize PK of CAB + RPV oral formulations when dispersed in liquid vs. directly ingested (Weight Bands 3, 4 and 5)
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Kampala, Mulago
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Uganda |
2023-03-16 12:55:20 |
2026-03-16 |
35 |
Children living with HIV-1, two years to less than 12 years of age and weighing ≥10 kg and <40 kg, who are Virologically suppressed on stable antiretroviral therapy and their parents/caregivers. Proposed the weight band dosing of oral cabotegravir (CAB) + oral rilpivirine (RPV) followed by long-acting injectable CAB (CAB LA) + long-acting injectable RPV (RPV LA) in children living with HIV-1, and to describe participant choice and experience with the regimen with or without an oral lead-in period. |
National Institute of Allergy and Infectious Diseases (NIAID) |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Peter Elyanu James
ID: UNCST-2021-R013210
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GS-US-380-1474: A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Adolescents and Children
REFNo: HS2708ES
This is a multisite, multi-cohort study that aims to recruit subjects in four weight-based cohorts (i.e. Cohort 1, 2, 3 and 4), with each cohort having specific objectives aligned with it. Baylor Uganda site will recruit subjects in cohort 4 with is further subdivided in 4 weight-based sub-groups. The study objectives in relation to the Cohort 4 are as follows;
Cohort 4
Group 1:
The primary objective of this study is:
• To evaluate the safety and tolerability of B/F/TAF 30/120/15 mg (administration of 2 B/F/TAF 15/60/7.5 mg FDC TOS) once daily through Week 24 in HIV-1 infected, virologically suppressed children ≥ 2 years of age weighing ≥ 14 to < 25 kg who are unable to swallow tablets
The secondary objectives of this study are:
• To evaluate the safety and tolerability of B/F/TAF 30/120/15 mg (administration of 2 B/F/TAF 15/60/7.5 mg FDC TOS) once daily through Week 48 in HIV-1 infected, virologically suppressed children ≥ 2 years of age weighing ≥ 14 to < 25 kg who are unable to swallow tablets
• To evaluate the antiviral activity of B/F/TAF 30/120/15 mg (administration of 2 B/F/TAF 15/60/7.5 mg FDC TOS) once daily through Weeks 24 and 48 in HIV-1 infected, virologically suppressed children ≥ 2 years of age weighing ≥ 14 to < 25 kg who are unable to swallow tablets
Group 2:
The primary objectives of this study are:
• To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 7.5/30/3.75 mg (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 10 to < 14 kg
• To evaluate the safety and tolerability of B/F/TAF 7.5/30/3.75 mg (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Week 24 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 10 to < 14 kg
The secondary objectives of this study are:
• To evaluate the safety and tolerability of B/F/TAF 7.5/30/3.75 mg (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Week 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 10 to < 14 kg
• To evaluate the antiviral activity of B/F/TAF 7.5/30/3.75 mg (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Weeks 24 and 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 10 to < 14 kg.
Group 3:
The primary objectives of this study are:
• To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 3.75/15/1.88 mg (administration of 1 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 6 to < 10 kg
• To evaluate the safety and tolerability of B/F/TAF 3.75/15/1.88 mg (administration of 1 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Week 24 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 6 to < 10 kg.
The secondary objectives of this study are:
• To evaluate the safety and tolerability of B/F/TAF 3.75/15/1.88 mg (administration of 1 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Week 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 6 to < 10 kg
• To evaluate the antiviral activity of B/F/TAF 3.75/15/1.88 mg (administration of 1 × B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Weeks 24 and 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 6 to < 10 kg.
Group 4:
The primary objectives of this study are:
• To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 1.88/7.5/0.94 mg (administration of 1 B/F/TAF 1.88/7.5/0.94 mg FDC TOS) twice daily in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 3 to < 6 kg.
• To evaluate the safety and tolerability of B/F/TAF 1.88/7.5/0.94 mg (administration of 1 B/F/TAF 1.88/7.5/0.94 mg FDC TOS) twice daily through Week 24 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 3 to < 6 kg
The secondary objectives of this study are:
• To evaluate the safety and tolerability of B/F/TAF 1.88/7.5/0.94 mg (administration of 1 B/F/TAF 1.88/7.5/0.94 mg FDC TOS) twice daily through Week 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 3 to < 6 kg
• To evaluate the antiviral activity of B/F/TAF 1.88/7.5/0.94 mg (administration of 1 B/F/TAF 1.88/7.5/0.94 mg FDC TOS) twice daily through Weeks 24 and 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 3 to < 6 kg
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Kampala, Mulago
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Uganda |
2023-03-16 12:47:17 |
2026-03-16 |
10 |
4.1 Selection of the Study Population
Approximately 170 pediatric subjects ≥ 1 month to < 18 years of age are planned to be enrolled into the entire study. However, 50 child subjects shall be recruited as follows for Cohort 4 across all participating sites; at least 8 evaluable subjects ≥ 2 years of age weighing ≥ 14 to < 25 kg and at least 42 evaluable subjects ≥ 1 month of age weighing ≥ 3 to < 14 kg are planned to be enrolled. Baylor Uganda site however, plans to recruit a total of 10 children in cohort 4 (i.e. 3 children in each of the groups 1, 2 and 3 and 1 child in group 1). In addition, replacement subjects may be enrolled for subjects whose Intensive PK data are not evaluable or who do not complete all Intensive PK procedures in Groups 2, 3, and 4 of Cohort 4.
4.2 Inclusion Criteria
Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
a) Age ≥ 1 month to < 18 years (according to requirements of enrolling Cohort)
b) Parent or legal guardian able to provide written informed consent prior to any screening evaluations and willing to comply with study requirements.
c) Body weight at screening for Cohort 4:
• Group 1: ≥ 14 to < 25 kg (≥ 31 to < 55 lbs)
• Group 2: ≥ 10 to < 14 kg (≥ 22 to < 31 lbs)
• Group 3: ≥ 6 to < 10 kg (≥ 13 to < 22 lbs)
• Group 4: ≥ 3 to < 6 kg (≥ 6.6 to < 13 lbs)
d) Confirmed HIV infection if < 18 months of age (positive nucleic acid-based test result to be provided).
e) Adequate renal function:
• Estimated Glomerular Filtration Rate (eGFR) ≥ 90 mL/min/1.73 m2 (≥ 1.5 mL/sec/1.73 m2) for children ≥ 1 year of age using the Schwartz Formula.
• Adequate renal function: eGFR ≥ the minimum normal values for age for children < 1 year of age using the Schwartz Formula.
o Schwartz formula (mL/min/1.73 m2) = k × L/SCr where k is a proportionality constant, L is height in centimetres (cm) and SCr is serum creatinine (mg/dL). The value of k is 0.45 for children < 1 year old, 0.55 for children ≥ 1 to < 12 years old and adolescent girls ≥ 12 years old and 0.70 for adolescent boys (≥ 12 years old).
f) Stable ARV regimen:
• Stable ARV regimen of 2 NRTIs in combination with a third agent for a minimum of 6 months prior to the screening visit. Subjects undergoing dose modifications to their ARV regimen for growth or who are switching medication formulation(s) are considered to be on a stable ARV regimen (Cohort 4 Group 1).
• Stable ARV treatment of 2 NRTIs in combination with a third agent for a minimum of 1 month prior to the screening visit or treatment naive (Cohort 4 Groups 2, 3, and 4 only) (patient is considered treatment naive if ARVs were given for prevention of mother-to-child transmission only and not for HIV treatment)
g) Plasma HIV-1 RNA: < 50 copies/mL at the screening visit (Cohort 4 Group 1). No threshold for HIV RNA levels for Cohort 4 Groups 2, 3, and 4.
h) Life expectancy ≥ 1 year.
i) Have no documented or suspected resistance to FTC, TFV, or INSTIs including, but not limited to, the reverse transcriptase resistance mutation K65R. Subjects with M184V/I AND HIV-1 RNA < 50 copies/mL may be enrolled in Cohort 4. Subjects in Cohort 4 with HIV-1 RNA > 50 copies/mL shall have documentation of no FTC, TFV, or INSTI resistance by plasma testing at screening (> 200 copies/mL) or historical genotype (if > 50 copies/mL but < 200 copies/mL).
j) Care taker(s) must be willing and able to comply with all study requirements.
4.3 Exclusion Criteria
Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
a) Cohort 4 Group 1: CD4 cell count < 200 cells/ mm3. Cohort 4 Groups 2, 3, and 4: CD4 cell count < 750 cells/mm3 for ≥1 to <12 months of age and < 500 cells/mm3 for ≥12 to <24 months of age.
b) An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening.
c) An ongoing serious infection requiring systemic antibiotic therapy at the time of screening
d) Evidence of active pulmonary or extra-pulmonary tuberculosis within 3 months
e) Acute hepatitis in the 30 days prior to study entry
f) Hepatitis B virus (HBV) surface antigen (HBsAg) positive
g) Hepatitis C virus (HCV) antibody positive with detectable HCV RNA. Children < 18 months of age born to an HCV positive mother and/or HCV antibody positive will need to have 2 negative HCV RNA tests 6 months apart with the first test occurring no earlier than 2 months of age. In this situation, the earliest such a patient can be screened for study eligibility is at 8 months of age.
h) Have any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include uncontrolled renal, cardiac, haematological, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment within 30 days prior to Day 1.
i) Subjects experiencing decompensated cirrhosis (eg, ascites, encephalopathy)
j) A history of or ongoing malignancy other than cutaneous Kaposi’s sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Subjects with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Day 1 and are not anticipated to require systemic therapy during the study.
k) ≤ 2 months of age and gestational age (GA) ≤ 37 weeks (Cohort 4 Groups 2, 3, and 4)
l) Current alcohol or substance abuse (by parent/caretaker) judged by the Investigator to potentially interfere with subject compliance
m) Have history of significant drug sensitivity or drug allergy
n) Known hypersensitivity to the IMP, the metabolites, or formulation excipients.
o) Participation in any other clinical trial, including observational studies without prior approval from sponsor is prohibited while participating in this trial.
p) Cohort 4 Groups 2, 3, and 4: Last dose of nevirapine (NVP) or efavirenz (EFV), if applicable, ≥ 14 days prior to enrolment
q) Subjects receiving ongoing therapy with any medication that is not to be taken with the study drug. Administration of any of the following medications must be discontinued at least 30 days prior to the Day 1 visit and for the duration of the study, with the exception of the subject’s prior ARV treatment regimen, which must be continued until their scheduled Day 1 visit
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Gilead Sciences, Inc. 333 Lakeside Drive Foster City, CA 94404 |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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