Conrad Muzoora Kihembe
ID: UNCST-2019-R001432
|
REDUCING MORTALITY IN ADULTS WITH ADVANCED HIV DISEASE (REVIVE)
REFNo: HS2892ES
To determine whether azithromycin is effective in reducing the incidence of new infection compared to placebo in adults with advanced HIV (CD4 ≤ 100 cells/mm3).,To determine whether azithromycin is effective in reducing mortality and hospitalisation at early and late timepoints (4weeks and 24weeks) compared to placebo in adults with advanced HIV (CD4 ≤ 100 cells/mm3).,To determine whether azithromycin is an effective and safe intervention to reduce excess mortality in adults with advanced HIV (CD4 ≤ 100 cells/mm3). ,
|
All Districts, Not applicable
|
Uganda |
2023-09-27 17:43:49 |
2026-09-27 |
8000 |
18 years and above, all sexes and all tribes |
Population Health Research Institute (PHRI) Canada |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Adoke Yeka
ID: UNCST-2021-R004300
|
PLATINUM: A multi-part, multi-center PLATform study to assess the efficacy, safety, tolerability and pharmacokinetics of anti-malarial agents administered as monotherapy at multiple dose levels and/or combination therapy IN patients with Uncomplicated Plasmodium falciparum Malaria.
REFNo: HS2817ES
Part A: To assess the parasite clearance time (PCT) of oral doses of an anti- malarial agent administered as monotherapy in patients with uncomplicated
P. falciparum malaria
Part B: To assess the effect on adjusted 28-day cure rate of an anti-malarial agent administered orally as combination therapy versus the standard of care (SoC) in patients with uncomplicated P. falciparum malaria.
Part A: To assess the effect on adjusted 28-day cure rate of an anti-malarial agent administered orally as monotherapy in patients with uncomplicated
P. falciparum malaria
Part B: To assess the parasite clearance time (PCT) of oral combinations of anti-malarial agents versus SoC in patients with uncomplicated P. falciparum malaria
All parts:
To characterize PK of each anti-malarial agent administered orally as monotherapy [Part A] and/or as combination therapy [Part B] in patients with uncomplicated P. falciparum malaria
To assess the safety and tolerability of each anti-malarial agent administered orally as monotherapy [Part A] and/or as combination therapy versus SoC [Part B] in patients with uncomplicated P. falciparum malaria
|
Tororo, Tororo
Tororo, Tororo
|
Uganda |
2023-09-26 11:55:15 |
2026-09-26 |
Part A 12,pART b18 |
The study population will consist of male and female patients aged ≥18 years for Part A and aged ≥12 years for Part B. |
Novartis |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Dennis Buwembo Rogers
ID: UNCST-2021-R011765
|
QUALITY OF SELF-CARE FOR OLDER (AGED 60 YEARS AND ABOVE) PEOPLE WITH DEMENTIA IN WAKISO DISTRICT, UGANDA. CAREGIVER PERCEPTIONS, AND EFFECTS OF A PSYCHOEDUCATION INTERVENTION ON QUALITY OF SELF-CARE.
REFNo: HS2958ES
To determine the effect of a remotely delivered psychoeducation intervention for caregivers of older people with dementia on the quality of self-care.,To explore the perception, caregivers of older people with dementia have towards quality of self-care.,To measure the quality of self-care for older people with dementia in Wakiso district, Uganda.,To Improve quality of self-care provided to older people with dementia through use of a remotely delivered psychoeducation intervention of caregivers of older people with dementia in Wakiso, district Uganda.,
|
Wakiso, Kiwenda
|
Uganda |
2023-09-19 7:51:22 |
2026-09-19 |
71 |
Caregivers of older people diagnosed with dementia, 18-70 years, both female and males, all tribes as applicable |
Brain Health Training Program |
Medical and Health Sciences |
Clinical Trial |
Degree Award |
|
Edrisa Mutebi Ibrahim
ID:
|
Safety of JNK61 in Healthy Human Volunteers.
REFNo: HS2474ES
To determine the effect of JNK61 on the blood sugar levels in healthy human volunteers.,To determine the safety of JNK61 in healthy human volunteers,
|
Kampala, Makerere University
|
Uganda |
2023-08-30 16:05:54 |
2026-08-30 |
50 |
Male and female adults of any tribe |
Government of Uganda through Makerere University Research and Innovations Fund |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Joseph Matovu KB
ID: UNCST-2020-R014654
|
Enhancing communication on relationship preservation, safer conception, and pre-exposure prophylaxis (PrEP) to promote HIV testing
REFNo: HS3025ES
Conduct a pilot trial of “PrEPing Healthy Families” with intervention sites implementing the novel communication,Conduct formative research to expand a communication strategy focused on relationship preservation and safer conception into a multi-component intervention with broader reach,To leverage the growing availability of PrEP to determine if and how a communication strategy focused on relationship preservation and safer conception can increase testing and entry into treatment (ART) or prevention (PrEP) among couples in Uganda,
|
Mukono, Ntaawo ward
Mityana, Central ward
Butambala, Gombe ward
|
Uganda |
2023-08-25 8:26:15 |
2026-08-25 |
267 |
The proposed study will recruit up to 267 total participants. These participants include project advisory board members (up to 25) clients in assisted partner notification (APN) or antenatal care (ANC) programs (up to 36 for in-depth interviews [IDIs], up to 150 for exit surveys), their partners (up to 36 for IDIs), and ANC/APN providers at the intervention site (up to 20).
Participants will all be aged 18 years and above and all sexes. |
Glenn Wagner |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Mark Kaddumukasa
ID: UNCST-2020-R001798
|
SELF MANAGEMENT INTERVENTION FOR REDUCING EPILEPSY BURDEN AMONG UGANDANS WITH EPILEPSY
REFNo: HS2944ES
1. To assess the efficacy of SMART- U vs. eTAU via an RCT.
H1: Individuals randomized to SMART-U will have significantly improved QOL and fewer seizures compared to eTAU.
H2: Individuals randomized to SMART-U will have greater improvement in depression and functional status compared to eTAU.
2. To use short message service (SMS) delivered via mobile phone text to validate patient self-reported seizure occurrence and push epilepsy self-management messaging in a practical/accessible format.
3. To obtain input from stakeholders (patients, family and clinicians) guided by an Integrated Promotion Action on Research Implementation in Health Services (i-PARIHS) framework to help establish sustainable infrastructure that will facilitate future scale up of SMART in Uganda with epilepsy partners
|
Kampala, Mulago
Mbarara, Mbarara
|
Uganda |
2023-08-25 8:11:10 |
2026-08-25 |
188 |
Target population: all adult patients attending the neurology clinic at Mulago and Mbarara hospitals.
Accessible population: All adult patients with epilepsy on treatment attending the clinic during the study period.
Study population: All adult patients with epilepsy on treatment who will meet the inclusion criteria from all tribes attuning the study clinics.
All consecutive adult patients who came either for follow up or as new referrals with confirmed diagnosis of epilepsy were screened for the inclusion into the study.
|
NIH/ USA |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Sharon Pang Sze Lu
ID:
|
Transform Randomised Controlled Trial in Uganda
REFNo: SS1823ES
To evaluate the impact of the Transform program on the key indicators in values, health and livelihood in Uganda
|
|
Hong Kong |
2023-08-25 8:07:30 |
2026-08-25 |
4800 |
The study population will include participants aged 18 to 90 years old. Both male and female participants are included in the study. ICM will first choose communities and identify 30 ultra-poor households for its Transform program (administered across control and treatment groups). Eligibility for Transform is determined using poverty assessment via an asset-based scoring and self-reported household income. Historically, there have been an average of 30 households per community. With a target sample size of 160 communities, we will have approximately 4,800 households in the study. ICM targets communities to receive a Transform program based on the proportion of community members living in ultra-poverty (less than USD $0.50/person/day).Participants who are above the threshold using the poverty assessment will be excluded from the study. Households also cannot participate in the study if they have previously received the Transform program, unless the implementation team overrides the score due to specific circumstances that only affect a minority of participants. |
International Care Ministries |
Social Science and Humanities |
Clinical Trial |
Non-degree Award |
|
Adoke Yeka
ID: UNCST-2021-R004300
|
An adaptive, randomized, active-controlled, open-label, sequential cohort,
multicenter study to evaluate the efficacy, safety, tolerability and
pharmacokinetics of intravenous cipargamin (KAE609) in adult and pediatric
participants with severe Plasmodium falciparum malaria (KARISMA –
KAE609’s Role In Severe Malaria)
REFNo: HS1980ES
Primary objective
To assess the efficacy of different doses of
intravenous cipargamin vs artesunate by evaluating the proportion of
participants with ? 90% reduction of parasitemia at 12 hours post
administration of the first dose.
Secondary Objectives
1. To assess the presence/absence of severe malaria related individual
signs over time
2. To evaluate parasite clearance dynamics and proportion of participants
with recrudescence and reinfection
3. To assess recovery of participants as measured by time (days and hours)
to discharge from hospital or recovery from prostration
4. To evaluate the safety and tolerability of IV cipargamin
5. To assess the risk of long term neurological sequelae for participants at
Day 29
6. The assess the risk of hemolysis (early and delayed) during the study
duration
7. To characterize the plasma pharmacokinetics of IV cipargamin
|
Tororo, Masafu
|
Uganda |
2023-08-18 9:05:14 |
2026-08-18 |
200 patients for AL treatment arm and 100 patients for the other treatment arms per site. At least two drugs will be studied per site |
The study population will consist of male and female participants, including
pediatric participants aged ? 6 months or older. Approximately 252
participants (60 participants of ? 12 years and 192 participants < 12 years)
will be randomized |
Novartis |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Henry Mugerwa
ID: UNCST-2019-R000420
|
PLATINUM: A multi-part, multi-center PLATform study to assess the efficacy, safety, tolerability and pharmacokinetics of anti-malarial agents administered as monotherapy at multiple dose levels and/or combination therapy IN patients with Uncomplicated Plasmodium falciparum Malaria
REFNo: HS2748ES
Main Objectives:
1. Part A: To assess the parasite clearance time (PCT) of oral doses of an anti- malarial agent administered as monotherapy in patients with uncomplicated P. falciparum malaria
2. Part B: To assess the effect on adjusted 28-day cure rate of an anti-malarial agent administered orally as combination therapy versus the standard of care (SoC) in patients with uncomplicated P. falciparum malaria
Secondary Objectives
1. Part A: To assess the effect on adjusted 28-day cure rate of an anti-malarial agent administered orally as monotherapy in patients with uncomplicated P. falciparum malaria
2. Part B: To assess the parasite clearance time (PCT) of oral combinations of anti-malarial agents versus SoC in patients with uncomplicated P. falciparum malaria
3. To characterize PK of each anti-malarial agent administered orally as monotherapy [Part A] and/or as combination therapy [Part B] in patients with uncomplicated P. falciparum malaria
4. To assess the safety and tolerability of each anti-malarial agent administered orally as monotherapy [Part A] and/or as combination therapy versus SoC [Part B] in patients with uncomplicated P. falciparum malaria
|
|
Uganda |
2023-08-10 13:49:44 |
2026-08-10 |
14 |
The study population will consist of male and female patients aged ≥18 years for Part A and aged ≥12 years for Part B. |
Novartis |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Bernard Kikaire
ID:
|
Effect of an interactive SMS system in improving the reporting of adverse drug reactions among people living with HIV in Tanzania and Uganda: a randomized controlled trial: The REMIND ADR TRIAL
REFNo: HS2922ES
To investigate the effectiveness of SMS reminders on improving ADR reporting compared to no SMS among people living with HIV in Tanzania and Kampala Uganda.
To describe the most commonly reported ADR profiles among people living with HIV in Tanzania and Uganda.
To determine the most common routes/ methods of reporting ADR used by PLHIV.
To explore the causal relationship between the commonly reported ADRs and ART.
To improve treatment options for participants who reported ADR.
To explore the technical feasibility and acceptability of the intervention in reporting ADR among PLHIV.
|
Kampala, mulago
|
Uganda |
2023-08-08 12:42:32 |
2026-08-08 |
114 |
Age between 18 and 65
confirmed and documented HIV infection
Being on ART treatment for less than one year
Able to read and understand SMS
Able to understand and willing to sign the informed consent document
Able to read and write a text message
Have a mobile phone
|
The study is funded by Eastern Africa Consortium for Clinical Research (EACCR3) which is a network of excellence under EDCTP |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Joseph Lutaakome
ID: UNCST-2020-R008323
|
Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE)
REFNo: HS2703ES
Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE) is a master protocol being conducted in many countries around the world, and funded by the National Institutes of Health, USA. STRIVE will evaluate the safety and effectiveness of unlicensed and licensed treatments and different combinations of treatments, to improve the health outcomes of adults
hospitalised with acute respiratory infections, like COVID-19 or influenza.
|
Kampala, Kampala
Masaka, Masaka
Gulu, Gulu
Lira, Lira
|
Uganda |
2023-08-08 12:39:21 |
2026-08-08 |
1,500 |
The participant population are non-pregnant or breast-feeding adults aged ≥ 18 years; with confirmed COVID-19 for <14 days, and requiring inpatient hospital acute medical care and with evidence of a COVID-19 lower respiratory tract infection. |
National Institutes of Health |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Harriet Mayanja-Kizza
ID: UNCST-2021-R013074
|
A phase 2, partially-blinded, randomised trial assessing the
safety and efficacy of TBAJ876 or bedaquiline, in combination
with pretomanid and linezolid in adult participants with newly
diagnosed, drug-sensitive, smear-positive pulmonary
tuberculosis
REFNo: HS2928ES
The objectives of the trial are to evaluate the efficacy, safety, and tolerability of TBAJ876 (3 doses) or bedaquiline in combination with pretomanid and linezolid in adult participants with newly diagnosed, smear-positive pulmonary DS-TB in comparison to the SOC
|
Kampala, Mulago
Kampala, Lubowa
|
Uganda |
2023-08-07 15:20:08 |
2026-08-07 |
The trial is planned to randomise at least 60 participants per treatment arm, for a total of at least 300 participants randomised. |
Study population should have the following characteristics:
1. Signed written informed consent prior to undertaking any trial-related procedures.
2. Participants aged 18 to 65 years, inclusive.
3. Body weight (in light clothing and no shoes) ≥35 kg.
4. Sputum positive for tubercle bacilli (at least 1+ on the IUATLD/WHO scale on smear
microscopy) at the trial laboratory.
5. DS-TB participants defined as the following:
a. Sensitive to rifampicin and isoniazid by rapid sputum-based test (see trial
Mycobacteriology Laboratory Manual) AND
b. Either newly diagnosed for TB or have a history of being untreated for at least 3
years after cure from a previous episode of TB.
6. A chest x-ray during the screening period or within 14 days of screening which in the
opinion of the investigator is compatible with pulmonary TB.
7. Be of non-childbearing potential OR using effective methods of birth control as defined
below:
Non-childbearing Potential
a. Participant is not heterosexually active or practices sexual abstinence OR
b. Female participant or male participant’s female sexual partner: bilateral
oophorectomy, bilateral tubal ligation, and/or hysterectomy or has been postmenopausal with a history of no menses for at least 12 consecutive months
OR
c. Male participant or female participant’s male sexual partner: vasectomized or
has had a bilateral orchidectomy at least 3 months prior to screening
Effective method of birth control is defined as 1 of the following:
a. Double-barrier method which can include a combination of male condom,
diaphragm, cervical cap, or female condom.
Note: Female and male condom should not be used together.
b. Combination of a barrier method with hormone-based contraceptives or an intrauterine device.
Both male and female participants must be willing to continue practicing birth control
methods and not be planning to conceive throughout treatment and for 6 months after
the last dose of IMP.
References to male or female mean “assigned male or female at birth,” respectively.
|
TB Alliance |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Proscovia Nabunya
ID: UNCST-2019-R000970
|
Say No to Stigma-Round 2: Pilot testing the impact of visuals designed to reduce mental health stigma among primary school students in Uganda
REFNo: SS1818ES
Examine the acceptability and preliminary impact of the Say No to Stigma visual solutions on children’s mental health awareness and stigma in schools.
|
|
Uganda |
2023-07-27 20:55:02 |
2026-07-27 |
100 |
One hundred (100) students in total will be recruited for this study.
Inclusion Criteria: Children: 1) ages between 8 to 13 (primary 2 to 7) enrolled in the selected school.
Exclusion Criteria: 1) inability to comprehend study procedures or participant rights as assessed by trained staff during the informed consent process; or 2) they are unwilling or unable to commit to completing the study.
|
Washington University in St. Louis |
Social Science and Humanities |
Clinical Trial |
Non-degree Award |
|
Grace Mirembe
ID: UNCST-2022-R008850
|
RV 591 entitled “A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of an Ad26.Mos4.HIV and CH505 TF chTrimer (Env) Combination to Mimic Acute HIV Viral Replication Kinetics in Healthy Adults”
REFNo: HS2891ES
To assess the safety, reactogenicity and tolerability of two vaccination regimens: rapid dose-escalation of CH505 TF chTrimer+ALFQ and Ad26.Mos4.HIV or co-administration of CH505 TF chTrimer+ALFQ and Ad26.Mos4.HIV
|
Kampala, Central
|
Uganda |
2023-07-14 9:49:16 |
2026-07-14 |
50 |
Healthy male and female participants, aged 18 to 50 years |
The Surgeon General, Department of the Army |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Joy Gumikiriza- Onoria Louise
ID:
|
Development of a Caregiver Centered Psychotherapy (CCPT) in addressing patient care for older persons with Alzheimer’s Disease and Related Dementias (ADRD) in Uganda.
REFNo: HS2909ES
1. To explore ways in which older people in the community of Wakiso district conceptualize ADRD and what informs their opinions. 2. To assess caregiver distress, non-professional techniques of patient care, quality of life and the associated factors among family caregivers of persons with ADRD in Wakiso district.To adapt and pre-test the WHO-iSupport for family caregivers of persons with ADRD in Wakiso, Uganda4. To determine the effectiveness of A-iSupport in the alleviation of distress among family caregivers of persons with ADRD in Wakiso, Uganda
|
Wakiso, Busukuma
Wakiso, Nansana
|
Uganda |
2023-07-14 9:40:03 |
2026-07-14 |
180 |
All residents of Wakiso district aged 60 years and older, includidng caregivers of persons with ADRD |
BRAIN health |
Medical and Health Sciences |
Clinical Trial |
Degree Award |
|
Nixon Niyonzima
ID: UNCST-2020-R014577
|
A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF GIREDESTRANT IN COMBINATION WITH PHESGO VERSUS PHESGO AFTER INDUCTION THERAPY WITH PHESGO-TAXANE IN PATIENTS WITH PREVIOUSLY UNTREATED HER2-POSITIVE, ESTROGEN RECEPTOR-POSITIVE LOCALLY-ADVANCED OR METASTATIC BREAST CANCER (HeredERA)
REFNo: HS2968ES
To identify and/or evaluate biomarkers that are predictive of response to Phesgo and giredestrant (i.e., predictive biomarkers), are early surrogates of efficacy, are associated with progression to a more severe disease state (i.e., prognostic biomarkers), are associated with acquired resistance to Phesgo and giredestrant, are associated with susceptibility to developing adverse events or can lead to improved adverse event monitoring or investigation (i.e., safety biomarkers), can provide evidence of Phesgo and giredestrant activity (i.e., pharmacodynamic biomarkers), or can increase the knowledge and understanding of disease biology and drug safety,To evaluate potential effects of ADAs,To evaluate the immune response to pertuzumab, trastuzumab, and rHuPH20,To evaluate the potential relationships between Phesgo and giredestrant exposure and the safety, efficacy, immunogenicity, or biomarker endpoints.,To characterize the giredestrant, pertuzumab, and trastuzumab PK profile when given in combination,To evaluate the safety of Phesgo plus giredestrant compared with Phesgo from the participant's perspective,To evaluate health utility of participants treated with Phesgo plus giredestrant compared with Phesgo to generate utility scores for use in economic models,To evaluate effects of Phesgo plus giredestrant compared with Phesgo on work productivity and activity,To evaluate the safety of Phesgo plus giredestrant compared with Phesgo,To evaluate the efficacy of Phesgo plus giredestrant compared with Phesgo,
|
Kampala, Mulago
|
Uganda |
2023-07-14 12:43:26 |
2026-07-14 |
20 |
This study will enrol patients with locally advanced or metastatic receptor positive breast cancer above 18 years of age |
La Roche Hoffman |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Angella Natukunda
ID:
|
DETERMINANTS OF NUTRITION STATUS AMONG ADOLESCENTS IN SELECTED SECONDARY SCHOOLS OF KANUNGU DISTRICT SOUTH WEST REGION UGANDA
REFNo: SS1812ES
Broad obective
To investigate the determinants of nutrition status among adolescents in selected secondary schools in Kanungu District South West Uganda.
Specific objectives
To assess the nutrition status of adolescents in the selected secondary schools of Kanungu District South West Region Uganda.
To determine the social demographic and economic factors influencing nutrition status of adolescents in the selected secondary schools of Kanungu District South West Region Uganda.
To determine the diet-related factors influencing nutrition status of adolescents in the selected secondary schools of Kanungu District South West Region Uganda.
To determine the level of adolescent nutrition knowledge associated with nutrition status among adolescents in the selected secondary schools of Kanungu District South West Region Uganda.
|
|
Uganda |
2023-07-14 12:34:44 |
2026-07-14 |
370 |
The study population will constitute of adolescents both male and female studying in secondary schools of Kanungu district 12 to 19 years. |
Natukunda Angella |
Social Science and Humanities |
Clinical Trial |
Degree Award |
|
Rhoda Wanyenze
ID: UNCST-2021-R013352
|
A Hybrid Implementation-Effectiveness Trial of Game Changers for Cervical Cancer Prevention (GC-CCP) in Uganda
REFNo: SS1873ES
1. Conduct a multisite RCT of the GC-CCP network-based advocacy strategy to evaluate effects on CC screening uptake, access to early-stage treatment and prevention of advanced disease among unscreened alters across urban/rural and public/private clinics,4. Evaluate the cost-effectiveness of Implementing GC-CCP to increase CC screening and low cost, early-stage treatment, and prevent advanced disease, compared to enhanced usual care.,3. Examine mediators and moderators (among index, alter and network characteristics) of intervention effects on (a) alter CC screening; and (b) engagement in CC prevention advocacy of index and alter (1st and 2nd degree) to better understand its multiplier effect on diffusion of advocacy throughout a network.,2. Use a mixed methods approach (semi-structured interviews and administrative clinic data) to examine clinic-, provider-, and client-level barriers and facilitators of GC-CCP Implementation and Sustainment.,
|
Kampala, Nsambya
Kampala, Kawempe
Buikwe, Buikwe
Kayunga, Kayunga
|
Uganda |
2023-07-13 11:13:19 |
2026-07-13 |
1400 women |
Women recently screened for Cancer of the Cervix and aged 25 years and above will be enrolled as index participants, Women who have not screened for Cancer of the Cervix but are network members of index participants will be enrolled as alter participants, Clinic leadership and providers of Cervical Cancer services will participate in qualitative interviews. |
National Institute of Mental Health |
Social Science and Humanities |
Clinical Trial |
Non-degree Award |
|
Nixon Niyonzima
ID: UNCST-2020-R014577
|
A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared with Physician’s Choice of Adjuvant Endocrine Monotherapy in Patients with Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (Lidera)
REFNo: HS2193ES
Main Objective
1. To demonstrate superiority of giredestrant over the control treatment.
Specific Objectives
1. To evaluate the efficacy of giredestrant compared with Therapy of Physician's Choice
2. To evaluate the safety of giredestrant compared with Therapy of Physician's Choice
3. To characterize giredestrant Pharmacokinetics
4. To evaluate health status utility scores of participants treated with giredestrant compared with Therapy of Physician's Choice
5. To evaluate the tolerability of giredestrant compared with Therapy of Physician's Choice
6. To identify and/or evaluate biomarkers that are predictive of response to giredestrant (i.e., predictive biomarkers), are early surrogates of efficacy, are associated with progression to a more severe disease state (i.e., prognostic biomarkers), are associated with acquired resistance to giredestrant, are associated with susceptibility to developing adverse events or can lead to improved adverse event monitoring or investigation (i.e., safety biomarkers), can provide evidence of giredestrant activity (i.e., pharmacodynamic biomarkers), or can increase the knowledge and understanding of disease biology and drug safety
|
Kampala, Mulago
|
Uganda |
2023-07-13 10:07:44 |
2026-07-13 |
18 |
women aged 18 years of age and over with histologically confirmed breast cancer |
Hoffman La Roche |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Flavia Matovu Kiweewa
ID: UNCST-2021-R013337
|
A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Adolescents and Children.
REFNo: HS2931ES
The primary objective of this study is to confirm the dose of B/F/TAF FDC in HIV-1 infected pediatric participants, to confirm the dose of B/F/TAF TOS in HIV-1 infected pediatric participants and to evaluate the safety and tolerability these medications.
|
Kampala,
|
Uganda |
2023-07-06 17:23:47 |
2026-07-06 |
5 |
Adolescents and children |
Gilead Sciences |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
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