Clinical trials: in Botswana
Tuberculosis, Multidrug-Resistant, Tuberculosis
Linezolid Dosing Strategies in Drug-Resistant TB
The purpose of the study was to evaluate the efficacy (how well the medicines work) and tolerability (whether participants stop treatment because of side effects from a drug) of an anti-TB treatment regimen that compared two…
- Conditions
- Tuberculosis, Multidrug-Resistant, Tuberculosis, Tuberculosis, Pulmonary
- Trial name
- NCT05007821
- Testing
- Linezolid 600 mg, Linezolid 1200 mg (QD), Linezolid 1200 mg (TIW)
- Where
- 13 sites in Botswana, Brazil and 5 more
- Volunteers
- 138 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Evaluating the Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants
The purpose of this study was to compare the virologic efficacy and safety of three antiretroviral (ARV) regimens, dolutegravir plus emtricitabine/tenofovir alafenamide, dolutegravir plus emtricitabine/tenofovir disoproxil…
- Trial name
- VESTED (NCT03048422)
- Testing
- Dolutegravir, Emtricitabine/tenofovir alafenamide, Emtricitabine/tenofovir disoproxil fumarate
- Where
- 21 sites in United States, Botswana and 7 more
- Volunteers
- 643 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, HIV Infections
Study of Limited Versus Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana
This is a randomized, blinded, two-arm comparative trial of continued versus limited isoniazid (INH) tuberculosis (TB) preventive therapy in HIV-infected adults in Gaborone and Francistown, Botswana.
- Trial name
- NCT00164281
- Testing
- Isoniazid
- Where
- Botswana
- Volunteers
- 1,995 people
- Sponsor
- Centers for Disease Control and Prevention
HIV-1-infection
Group-Based Intervention to Improve Mental Health and Adherence Among Youth Living With HIV in Low Resource Settings
IMPAACT 2016 was a multi-site, two-arm, individually randomized, controlled study to evaluate whether an Indigenous Leader Outreach Model (ILOM) of trauma-informed cognitive behavioral therapy (TI-CBT) delivered by Indigenous…
- Trial name
- NCT04024488
- Testing
- Youth TI-CBT Intervention Arm, Youth Discussion Control Arm, Caregiver TI-CBT Intervention Arm
- Where
- 8 sites in Botswana, Malawi and 2 more
- Volunteers
- 484 people
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
HIV Infection
Dual bNAb Treatment in Children
The purpose of this study is to evaluate the impact of two broadly neutralizing antibodies, VRC01LS and 10-1074, on the maintenance of HIV suppression in a cohort of early-treated children in Botswana.
- Trial name
- NCT03707977
- Testing
- ART, VRC01LS, 10-1074
- Where
- 2 sites in Botswana
- Volunteers
- 30 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
SARS-CoV-2 Infection, HIV Infections
Efficacy Study of COVID-19 mRNA Vaccine in Regions With SARS-CoV-2 Variants of Concern
The study will evaluate the clinical efficacy of different dosing regimens of the Moderna COVID-19 mRNA vaccine (100 mcg) in preventing COVID-19 disease in people who are living with HIV or have comorbidities associated with…
- Conditions
- SARS-CoV-2 Infection, HIV Infections, COVID-19
- Trial name
- CoVPN3008 (NCT05168813)
- Testing
- Moderna mRNA-1273, Moderna mRNA-1273.222, Vaccine 3 Dose
- Where
- 47 sites in Botswana, Eswatini and 5 more
- Volunteers
- 14,237 people
- Sponsor
- COVID-19 Prevention Network
HIV Infection
Analytical Treatment Interruption (ATI) to Assess the Immune System's Ability to Control HIV in Participants Who Became HIV-infected During the HVTN 703/HPTN 081 AMP Study
The purpose of this study is to learn whether having the AMP Study antibody (called VRC01) in a person's body might help their immune system control HIV better, even without HIV medication called antiretroviral therapy or ART, if…
- Trial name
- NCT04860323
- Testing
- Analytical Treatment Interruption
- Where
- 11 sites in Botswana, Malawi and 2 more
- Volunteers
- 13 people
- Sponsor
- HIV Vaccine Trials Network
HIV Infections
Dolutegravir Study in HIV-1 Participants Completing IMPAACT Studies P1093 and P2019
Dolutegravir is a potent integrase strand transfer inhibitor. Abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) is a fixed dose combination regimen containing two nucleoside reverse transcriptase inhibitors and dolutegravir.
- Trial name
- NCT03016533
- Testing
- Dolutegravir film-coated tablets, Dolutegravir film-coated dispersible tablets, ABC/DTG/3TC immediate release tablets
- Where
- 17 sites in United States, Botswana and 5 more
- Volunteers
- 100 people
- Sponsor
- ViiV Healthcare
HIV Infections
More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents
The purpose of this study was to determine the dosage for oral cabotegravir (CAB) and long-acting cabotegravir (CAB LA) and long-acting rilpiverine (RPV LA) and evaluate the safety, acceptability, tolerability, and…
- Trial name
- MOCHA (NCT03497676)
- Testing
- Oral Cabotegravir (CAB), Oral Rilpivirine (RPV), Long-Acting Injectable Cabotegravir (CAB LA)
- Where
- 19 sites in United States, Botswana and 3 more
- Volunteers
- 168 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
IMPAACT P1026s is a Phase IV prospective clinical study to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants.
- Trial name
- NCT00042289
- Testing
- atazanavir/cobicistat, darunavir/ritonavir dosage #1, darunavir/ritonavir dosage #2
- Where
- 62 sites in United States, Argentina and 6 more
- Volunteers
- 1,578 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women
This study will evaluate the safety and efficacy of the long-acting injectable agent cabotegravir (CAB LA) compared to daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for pre-exposure prophylaxis (PrEP) in…
- Trial name
- NCT03164564
- Testing
- Oral CAB, Oral TDF/FTC, CAB LA
- Where
- 20 sites in Botswana, Eswatini and 5 more
- Volunteers
- 3,224 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV, Cardiovascular Diseases
Evaluating the Use of Pitavastatin to Reduce the Risk of Cardiovascular Disease in HIV-Infected Adults
People with HIV are at risk for cardiovascular disease (CVD). This study evaluated the use of pitavastatin to reduce the risk of CVD in adults with HIV on antiretroviral therapy (ART).
- Trial name
- REPRIEVE (NCT02344290)
- Testing
- Pitavastatin
- Where
- 137 sites in United States, Botswana and 11 more
- Volunteers
- 7,769 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infection, Hepatitis B
B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B
The purpose of this study was to evaluate response to and safety of the HBV vaccine HEPLISAV-B in two study populations of people living with HIV: prior HBV vaccine recipients who are deemed non-responders and individuals who are…
- Trial name
- BEe-HIVe (NCT04193189)
- Testing
- HEPLISAV-B, ENGERIX-B
- Where
- 41 sites in United States, Botswana and 8 more
- Volunteers
- 638 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Chlamydia Trachomatis Infection, Neonatal Infection
Antenatal Chlamydia Trachomatis and Neisseria Gonorrhoeae Testing to Prevent Adverse Neonatal Consequences
To assess the effectiveness of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) testing and treatment during pregnancy to reduce adverse pregnancy and birth outcomes compared to the standard of care (treatment based on…
- Conditions
- Chlamydia Trachomatis Infection, Neonatal Infection, Preterm Birth, Gonorrhea
- Trial name
- NCT04955717
- Testing
- Chlamydia trachomatis and Neisseria gonorrhoeae screening using the GeneXpert
- Where
- 2 sites in United States, Botswana
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- University of Southern California
HIV Infections
Safety of and Immune Response to Dolutegravir in HIV-1 Infected Infants, Children, and Adolescents
Dolutegravir (DTG) is an HIV drug in the integrase inhibitor drug class. This study evaluated the pharmacokinetics (PK), safety, tolerability of and immune response to DTG when used concurrently with optimized background therapy…
- Trial name
- NCT01302847
- Testing
- DTG film-coated tablets, DTG granules for suspension, DTG dispersible tablets
- Where
- 33 sites in United States, Botswana and 6 more
- Volunteers
- 181 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infection, LTBI
Drug-Drug Interactions Between Rifapentine and Dolutegravir in HIV/LTBI Co-Infected Individuals
This study evaluated the potential drug-drug interactions between dolutegravir (DTG) and steady state rifapentine (RPT) when RPT was given with isoniazid (INH) daily for 4 weeks (1HP) as part of treatment for latent TB infection…
- Trial name
- NCT04272242
- Testing
- Dolutegravir (DTG), Isoniazid (INH), Rifapentine (RPT)
- Where
- 10 sites in United States, Botswana and 5 more
- Volunteers
- 37 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV
Mopati: A Pilot Hiv Treatment Partner Intervention In Botswana
This study is a pilot test of the Mopati program ("partner" in Setswana), which is a multi-level intervention that guides healthcare providers and patients about treatment partner selection, and trains treatment partners on…
- Trial name
- NCT04796610
- Testing
- Mopati
- Where
- Botswana
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- RAND
HIV Infection
IMPAACT 1077HS: Examining Benefits of HAART Continuation in Postpartum Women
This study was a randomized strategy trial conducted among women who received highly active antiretroviral therapy (HAART) during pregnancy for purposes of prevention of mother-to-child transmission (PMTCT) of HIV but did not…
- Trial name
- NCT00955968
- Testing
- Highly active antiretroviral therapy (HAART)
- Where
- 50 sites in United States, Argentina and 7 more
- Volunteers
- 1,653 people
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
HIV Infections
The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age
The purpose of this study was to examine the pharmacokinetics, safety, and tolerability of abacavir/dolutegravir/lamivudine dispersible and immediate release tablets in children living with HIV less than 12 years of age.
- Trial name
- NCT03760458
- Testing
- Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets, Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release)
- Where
- 14 sites in United States, Botswana and 2 more
- Volunteers
- 57 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Evaluating the Safety and Antiviral Activity of Monoclonal Antibody VRC01 in Infants With HIV Receiving Combination Antiretroviral Therapy
The purpose of this study was to evaluate the safety and antiviral activity to promote clearance of HIV-1 infected cells of VRC01 in infants with HIV beginning combination antiretroviral therapy (cART).
- Trial name
- NCT03208231
- Testing
- VRC01, Combination Antiretroviral Therapy (cART)
- Where
- 7 sites in Botswana, Brazil and 2 more
- Volunteers
- 61 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)