Clinical trials: completed, in Mozambique
HIV Infections
Safety and Immunogenicity of Clade C ALVAC and gp120 HIV Vaccine
The purpose of this study is to evaluate the safety and immune response to an HIV clade C vaccine and to an MF59- or alum-adjuvanted clade C Env protein in healthy, HIV-uninfected adults.
- Trial name
- HVTN107 (NCT03284710)
- Testing
- ALVAC-HIV (vCP2438), Bivalent Subtype C gp120/MF59, Bivalent Subtype C gp120 admixed with Al(OH)3 Suspension
- Where
- 6 sites in Mozambique, South Africa and 1 more
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Severe Malaria
To Evaluate Efficacy, Safety, Tolerability and PK of Intravenous Cipargamin in Participants With Severe Plasmodium Falciparum Malaria
The purpose of this study was to identify the safe and effective dose of intravenous cipargamin in participants with moderately severe and severe malaria.
- Trial name
- NCT04675931
- Testing
- Cipargamin, IV Artesunate, Coartem
- Where
- 9 sites in Burkina Faso, Côte d’Ivoire and 5 more
- Volunteers
- 254 people
- Sponsor
- Novartis Pharmaceuticals
Depression, Adolescent Behavior
Adolescent Depression Screening and Treatment in Mozambican Primary Care
This is a cluster-randomized pilot trial of depression screening and treatment implementation at four Youth-friendly Health Services (YFHS) in primary care clinics, two in Maputo City and two in Maputo Province.
- Trial name
- NCT05476237
- Testing
- Group Interpersonal Therapy for Adolescents (IPT-AG), Treatment as Usual (TAU)
- Where
- 4 sites in Mozambique
- Volunteers
- 95 people
- Sponsor
- Columbia University
Hiv
Estamos Juntos (We Are Together): Improving HIV Care Delivery by Capacitating Health Care Providers
Health care workers' negative behavior towards patients (likely a reflection of low job satisfaction, frustration with delivering HIV care and treatment in extremely resource-limited settings, and burnout) is one of the primary…
- Trial name
- NCT05938621
- Testing
- behavioral therapy and education
- Where
- Mozambique
- Volunteers
- 28,448 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University Medical Center
Acute Malaria
Phase IIa Proof of Concept Study of M5717-Pyronaridine in Adults and Adolescents With Acute Uncomplicated Plasmodium Falciparum Malaria (CAPTURE 1)
The purpose of this study was to evaluate the safety, efficacy, and pharmacokinetic of the combination M5717 plus pyronaridine in participants with acute uncomplicated Plasmodium falciparum malaria.
- Trial name
- NCT05689047
- Testing
- M5717 330 mg, M5717 500 mg, M5717 660 mg
- Where
- 5 sites in Burkina Faso, Gabon and 2 more
- Volunteers
- 38 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
COVID-19
Characterising Transmission of SARS-CoV-2 in a Peri-urban Population in Mozambique
A population-based COVID19 surveillance in a household cohort will be set-up using an existing Household demographic surveillance system (HDSS).
- Trial name
- AfriCoVER (NCT04442165)
- Where
- Mozambique
- Volunteers
- 6,049 people, healthy volunteers welcome
- Sponsor
- Institute of Tropical Medicine, Belgium
Hemorrhagic Fever, Ebola
Safety, Tolerability and Immunogenicity Study of 2-dose Heterologous Regimens for Ebola Vaccines Ad26.ZEBOV/MVA-BN-Filo
The purpose of this study is to assess the safety, tolerability and immunogenicity of different vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as 2-dose heterologous regimens in healthy and…
- Trial name
- NCT02598388
- Testing
- Ad26.ZEBOV, MVA-BN-Filo
- Where
- 7 sites in United States, Kenya and 4 more
- Volunteers
- 578 people, healthy volunteers welcome
- Sponsor
- Janssen Vaccines & Prevention B.V.
HIV/AIDS, Hypertension
Systems Analysis and Improvement Approach for the Hypertension Care Cascade
As undiagnosed and untreated hypertension is one of the largest drivers of cardiovascular disease in sub-Saharan Africa approaches are needed to optimize the hypertension care cascade.
- Trial name
- SAIA-HTN (NCT04088656)
- Testing
- Systems Analysis and Improvement Approach for Hypertension Screening and Treatment Optimization
- Where
- 16 sites in Mozambique
- Volunteers
- 305 people
- Sponsor
- University of Washington
HIV Infections
Storytelling to Increase Family Support for Pre Exposure Prophylaxis Use
Pre-exposure prophylaxis (PrEP) is highly effective at preventing HIV infection but requires high levels of medication adherence, particularly among women.
- Trial name
- PrEP (NCT04071470)
- Testing
- Storytelling, PrEP
- Where
- Mozambique
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University Medical Center
Human Immunodeficiency Virus
Partners-based HIV Treatment for Couples Attending Antenatal Care
The purpose of this R01 proposal is to evaluate the clinical impact, hypothesized mechanisms of behavior change, and cost-effectiveness of a partners-focused integrated elimination of mother-to-child transmission of HIV (EMTCT)…
- Trial name
- NCT03149237
- Testing
- Couples-based services
- Where
- Mozambique
- Volunteers
- 2,160 people
- Sponsor
- Vanderbilt University Medical Center
HIV Infections
Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection in Women
This study will evaluate the safety and efficacy of the human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB (VRC01) in preventing HIV-1 infection in high-risk, HIV-uninfected women.
- Trial name
- NCT02568215
- Testing
- VRC01
- Where
- 21 sites in Botswana, Kenya and 5 more
- Volunteers
- 1,924 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Acute Uncomplicated Plasmodium Falciparum Malaria
Efficacy and Safety of KAF156 in Combination With LUM-SDF in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria
This study was designed to determine the most effective and tolerable dose at the shortest dosing regimen of the investigational drug KAF156 in combination with a solid dispersion formulation of lumefantrine (LUM-SDF) in…
- Trial name
- NCT03167242
- Testing
- KAF156, Coartem, Lumefantrine Solid Dispersion Formulation
- Where
- 11 sites in Burkina Faso, Gabon and 7 more
- Volunteers
- 524 people
- Sponsor
- Novartis Pharmaceuticals
Malaria
Pyronaridine Artesunate 3:1 Granule Formulation vs. Coartem© Crushed Tablets in P. Falciparum Malaria Pediatric Patients
The primary objective of this Phase III clinical study is to demonstrate the efficacy of the fixed combination of pyronaridine artesunate (PA) granule formulation (60:20 mg; pediatric PYRAMAX®) by showing a PCR-corrected adequate…
- Trial name
- NCT00541385
- Testing
- pyronaridine artesunate, arthemeter lumefantrine
- Where
- 8 sites in Burkina Faso, Côte d’Ivoire and 6 more
- Volunteers
- 535 people
- Sponsor
- Medicines for Malaria Venture
Malaria
Pyronaridine Artesunate (3:1) Versus Coartem® in P Falciparum Malaria Patients
The primary objective of this phase III study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) with that of Coartem® (artemether lumefantrine, AL) in children and adults…
- Trial name
- NCT00422084
- Testing
- Pyronaridine artesunate, Coartem® (artemether lumefantrine)
- Where
- 10 sites in Democratic Republic of the Congo, Ghana and 7 more
- Volunteers
- 1,272 people
- Sponsor
- Medicines for Malaria Venture
HIV/AIDS
Traditional Healers as Adherence Partners for Persons Living With HIV in Rural Mozambique
The overall goal of this project is to adapt and assess the impact of a traditional healer training program/intervention on the adherence, retention, and viral load of HIV infected patients newly initiated on anti-retroviral…
- Trial name
- PLHIV (NCT03076359)
- Testing
- Traditional Healer Support Program, Standard of Care
- Where
- Mozambique
- Volunteers
- 320 people
- Sponsor
- Vanderbilt University Medical Center
Malaria
Efficacy of GSK Biologicals' Candidate Malaria Vaccine 257049 Against Malaria Disease in Infants and Children in Africa
The purpose of this observer-blind study is to gather key efficacy, safety, and immunogenicity information on GSK's candidate malaria vaccine in infants and children.
- Trial name
- NCT00866619
- Testing
- Malaria Vaccine 257049, Meningococcal C Conjugate Vaccine, Cell-culture rabies vaccine
- Where
- 10 sites in Burkina Faso, Gabon and 5 more
- Volunteers
- 15,459 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pregnancy, Newborn Health
Study to Identify Factors Influencing Access of Pregnant Women and Their Infants to Local Healthcare Systems
This study collected information regarding the factors that might influence access of pregnant women to the local healthcare system. The main visits of the study screened \& enrollment, delivery and 90 day infant follow-up.
- Trial name
- NCT01734434
- Where
- 10 sites in Dominican Republic, Mozambique and 2 more
- Volunteers
- 3,243 people
- Sponsor
- Novartis Vaccines
Malaria
Examine Safety and Immune Responses of GSK 257049 Vaccine When Administered to Infants Living in a Malaria-endemic Region
GSK Biologicals is developing in partnership with the Program for Appropriate Technology in Health (PATH) Malaria Vaccine Initiative a candidate malaria vaccine for the routine immunization of infants and children living in…
- Trial name
- NCT00197028
- Testing
- RTS,S/AS02D, TETRActHib™, Engerix-B®
- Where
- Mozambique
- Volunteers
- 214 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tuberculosis
Study of AERAS-402 in Healthy Infants
AERAS-402 will be given to infants of at least 16 weeks of age who have already been vaccinated with BCG to determine if AERAS-402 will increase protection of infants to tuberculosis.
- Trial name
- NCT01198366
- Testing
- AERAS-402 1.5 x 10^10 vp, AERAS-402 3.0 x 10^10 vp, AERAS-402 1.0 x 10^11 vp
- Where
- 7 sites in Kenya, Mozambique and 1 more
- Volunteers
- 487 people, healthy volunteers welcome
- Sponsor
- Aeras
Uncomplicated Plasmodium Falciparum Malaria
Phase II Efficacy Study of Artefenomel & Piperaquine in Adults & Children With P. Falciparum Malaria.
A randomised, double-blind single-dose study to determine the efficacy, safety, tolerability and pharmacokinetics of OZ439 (artefenomel) in combination with piperaquine (PQP) in patients > 0.5 years and <= 70 years of age with…
- Trial name
- NCT02083380
- Testing
- Artefenomel 800mg: piperaquine 640mg, Artefenomel 800mg: piperaquine 960mg, Artefenomel 800mg: piperaquine 1440mg
- Where
- 9 sites in Benin, Burkina Faso and 5 more
- Volunteers
- 448 people
- Sponsor
- Medicines for Malaria Venture