Clinical trials: in Botswana
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)
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)
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 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)
HIV Infections, Tuberculosis
Pharmacokinetic Study to Evaluate Double-Dose Levonorgestrel Emergency Contraception in Combination With Efavirenz-Based Antiretroviral Therapy or Rifampicin-Containing Anti-Tuberculosis Therapy
The purpose of this pharmacokinetic (PK) study was to evaluate if a double dose (3 mg) of levonorgestrel (LNG) overcomes known drug-drug interactions (DDIs) with efavirenz (EFV)-based antiretroviral therapy (ART) or rifampicin…
- Trial name
- NCT03819114
- Testing
- Levonorgestrel (LNG)
- Where
- 18 sites in United States, Botswana and 5 more
- Volunteers
- 122 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
HIV Infection, Rotavirus Infection
Safety and Immune Response of a Rotavirus Vaccine in HIV-infected and Uninfected Children Born to HIV-infected Mothers
Rotavirus is the leading cause of severe diarrhea in infants and young children, accounting for 45% of severe diarrhea disease in both developed and developing countries.
- Trial name
- NCT00880698
- Testing
- RotaTeq
- Where
- 6 sites in Botswana, Tanzania and 2 more
- Volunteers
- 202 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections, Tuberculosis
Evaluating the Safety of Immediate Versus Deferred Isoniazid Preventive Therapy Among HIV-Infected Pregnant Women
Tuberculosis (TB) is a leading cause of death among HIV-infected persons in low-income settings and can be a serious complication for HIV-infected pregnant women and their infants.
- Trial name
- NCT01494038
- Testing
- Isoniazid (INH)
- Where
- 13 sites in Botswana, Haiti and 6 more
- Volunteers
- 956 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, HIV Infections
Brief Rifapentine-Isoniazid Evaluation for TB Prevention (BRIEF TB)
HIV-infected people have an increased risk of developing active tuberculosis (TB). At the time the study was designed, the standard course of treatment for TB was 6 to 9 months of isoniazid (INH).This study compared the safety…
- Trial name
- NCT01404312
- Testing
- Rifapentine (RPT), Isoniazid (INH), Pyridoxine (Vitamin B6)
- Where
- 45 sites in United States, Botswana and 8 more
- Volunteers
- 3,000 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Trizivir Vs. Kaletra and Combivir for the Prevention of Mother-to-Child Transmission of HIV
Anti-HIV drug regimens have dramatically improved the rates of prevention of mother-to-child transmission (MTCT) of HIV in developed countries.
- Trial name
- NCT00270296
- Testing
- Trizivir, Lamivudine/Zidovudine, Lopinavir/Ritonavir
- Where
- 4 sites in Botswana
- Volunteers
- 730 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Safety and Pharmacokinetics (PK) of Raltegravir in HIV (Human Immunodeficiency Virus)-Infected Children and Adolescents
Integrase is 1 of 3 HIV (Human Immunodeficiency Virus)-1 enzymes required for viral replication. Raltegravir is a drug that prevents integrase from working properly.
- Trial name
- NCT00485264
- Testing
- Raltegravir poloxamer film coated tablet, Raltegravir chewable tablet, Raltegravir oral granules for suspension (20 mg/mL)
- Where
- 42 sites in United States, Argentina and 4 more
- Volunteers
- 153 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hiv
Prospective Cohort Study of Adolescents Living With HIV and Their Caregivers Attending a Psychosocial Programme in Botswana
Adolescents/young adults with perinatally acquired HIV (PAH) face a number of antiretroviral (ART) adherence and well-being challenges.
- Trial name
- NCT03571555
- Testing
- Sentebale Psychosocial Programme
- Where
- Botswana
- Volunteers
- 516 people
- Sponsor
- Royal Holloway University
HIV Infection, Tuberculosis
Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers With HIV
Tuberculosis (TB) is highly endemic in sub-Saharan Africa. The increased burden of TB in settings with high prevalence of the Human Immunodeficiency Virus (HIV) is associated with high rates of transmission of Mycobacterium…
- Conditions
- HIV Infection, Tuberculosis, Pneumocystis Jiroveci Pneumonia
- Trial name
- NCT00080119
- Testing
- Isoniazid (INH), Trimethoprim/Sulfamethoxazole (TMP/SMX)
- Where
- 6 sites in Botswana, South Africa
- Volunteers
- 1,354 people, healthy volunteers welcome
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
HIV Infections
NNRTI vs PI Regimens for HIV Infected Women After They Have Taken Nevirapine to Prevent Mother-To-Child HIV Transmission
Non-nucleoside reverse transcriptase inhibitors (NNRTIs) are commonly included in anti-HIV drug regimens. However, HIV infected women who have previously taken the single dose NNRTI nevirapine (SD NVP) for the prevention of…
- Trial name
- OCTANE (NCT00089505)
- Testing
- Emtricitabine, Emtricitabine/Tenofovir disoproxil fumarate, Lopinavir/Ritonavir
- Where
- 11 sites in Botswana, Kenya and 5 more
- Volunteers
- 745 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
HIV Infection, Tuberculosis
Immediate Versus Deferred Start of Anti-HIV Therapy in HIV-Infected Adults Being Treated for Tuberculosis
The purpose of this study is to determine the best time to begin anti-HIV treatment in individuals who have HIV and tuberculosis (TB).
- Trial name
- STRIDE (NCT00108862)
- Testing
- Strategy: Immediate ART, Strategy: Deferred ART
- Where
- 26 sites in United States, Botswana and 11 more
- Volunteers
- 809 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections