Clinical trials: in Malawi
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-1
A Study to Assess the Efficacy of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-Adjuvanted Clade C gp140 in Preventing Human Immunodeficiency Virus (HIV) -1 Infection in Women in Sub-Saharan Africa
The primary purpose of this study is to assess the preventive vaccine efficacy (VE), safety and tolerability of a heterologous prime/boost regimen utilizing Ad26.Mos4.HIV and aluminum-phosphate adjuvanted Clade C gp 140 for the…
- Trial name
- NCT03060629
- Testing
- Ad26.Mos4.HIV, Clade C gp140
- Where
- 23 sites in Malawi, Mozambique and 3 more
- Volunteers
- 2,636 people, healthy volunteers welcome
- Sponsor
- Janssen Vaccines & Prevention B.V.
Tuberculosis, Pediatric
TB Innovation Project: A Pre- and Post- Implementation Assessment (TIPPI)
This evaluation will be conducted in ten countries involved in the Catalyzing Pediatric TB Innovation (CaP-TB) project: Cameroon, Cote D'Ivoire, Democratic Republic of Congo, Kenya, Lesotho, Malawi, Tanzania, Uganda, Zimbabwe and…
- Trial name
- TIPPI (NCT03948698)
- Testing
- Innovative approached to pediatric TB care
- Where
- 10 sites in Cameroon, Côte d’Ivoire and 8 more
- Volunteers
- 4,159,533 people
- Sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
Depression
The Sub-Saharan Africa Regional Partnership for Mental Health Capacity Building
This is a 10-site cluster-randomized implementation science trial that compares two clinic-level implementation strategies to facilitate ongoing Ministry of Health efforts to scale up depression treatment within non-communicable…
- Trial name
- SHARP (NCT03711786)
- Testing
- Basic implementation package, Enhanced implementation package
- Where
- 12 sites in Malawi
- Volunteers
- 946 people
- Sponsor
- University of North Carolina, Chapel Hill
HIV Prevention
Rectal Microbicide Acceptability, Tolerability and Adherence
MTN-035 is a multi-site, randomized-sequence, three-period, open label crossover study that will enroll approximately 210 participants randomized (1:1:1:1:1:1) to one of six sequences of rectal microbicide placebo product…
- Trial name
- NCT03671239
- Where
- 7 sites in United States, Malawi and 3 more
- Volunteers
- 217 people, healthy volunteers welcome
- Sponsor
- Microbicide Trials Network
HIV-1-infection, Antenatal Care
An Integrated Strategy to Support Antiretroviral Therapy and Pre-exposure Prophylaxis Adherence for HIV Prevention in Pregnant and Breastfeeding Women
This study is composed of two parallel, pilot randomized groups that will obtain preliminary data about the the acceptability, fidelity, and clinical outcomes associated with a multi-component adherence support strategy for HIV…
- Trial name
- NCT04330989
- Testing
- iNSC and Adherence supporter training
- Where
- Malawi
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV Infections
Phase 3 Safety and Effectiveness Trial of Dapivirine Vaginal Ring for Prevention of HIV-1 in Women
This is a double-blind, randomised, placebo-controlled study to assess the safety and efficacy of a silicone elastomer vaginal matrix ring.
- Trial name
- ASPIRE (NCT01617096)
- Testing
- Dapivirine Vaginal Ring
- Where
- 7 sites in Malawi, South Africa and 2 more
- Volunteers
- 2,629 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
Childhood Mortality
Mortality Reduction After Oral Azithromycin: Mortality Study
Our long-term goal is to more precisely define the role of mass azithromycin treatments as an intervention for reducing childhood mortality.
- Trial name
- MORDORIMort (NCT02047981)
- Testing
- Azithromycin
- Where
- 6 sites in United States, Malawi and 3 more
- Volunteers
- 190,238 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Human Immunodeficiency Virus
Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in Women
HIV Open-label Prevention Extension (HOPE).
- Trial name
- NCT02858037
- Testing
- Dapivirine Vaginal Ring
- Where
- 17 sites in Malawi, South Africa and 2 more
- Volunteers
- 1,456 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
HIV
Daily Trimethoprim-sulfamethoxazole or Weekly Chloroquine Among Adults on ART in Malawi
The purpose of this study is to determine if there is a benefit to taking trimethoprim-sulfamethoxazole (TS) as prophylaxis among HIV positive adults who have viral load suppression and a good clinical response on anti-retroviral…
- Trial name
- TSCQ (NCT01650558)
- Testing
- Standard of Care prophylaxis, Chloroquine (CQ) prophylaxis
- Where
- 2 sites in Malawi
- Volunteers
- 1,499 people
- Sponsor
- University of Maryland, Baltimore
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)
HIV Infections
Evaluating Strategies to Reduce Mother-to-Child Transmission of HIV Infection in Resource-Limited Countries
The purpose of this study was to examine, in an integrated and comprehensive fashion, three critical questions currently facing HIV-infected pregnant and postpartum women and their infants: 1.
- Trial name
- PROMISE (NCT01061151)
- Testing
- Zidovudine (ZDV), Nevirapine (NVP): Antepartum Mothers, Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]) tail
- Where
- 14 sites in India, Malawi and 5 more
- Volunteers
- 3,747 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 Infections
Preventing Sexual Transmission of HIV With Anti-HIV Drugs
This study will determine whether anti-HIV drugs can prevent the sexual transmission of HIV among couples in which one partner is HIV infected and the other is not.
- Trial name
- NCT00074581
- Testing
- Atazanavir, Didanosine, Efavirenz
- Where
- 17 sites in United States, Botswana and 7 more
- Volunteers
- 3,526 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Comparison of Three Anti-HIV Regimens to Prevent Nevirapine Resistance in Women Who Take Nevirapine During Pregnancy
HIV infected pregnant women may take single-dose nevirapine (SD NVP) prior to giving birth to prevent mother-to-child transmission (MTCT) of HIV.
- Trial name
- NCT00099632
- Testing
- Emtricitabine/Tenofovir Disoproxil Fumarate, Lamivudine/Zidovudine, Lopinavir/Ritonavir
- Where
- 8 sites in Haiti, India and 4 more
- Volunteers
- 484 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)
Tuberculosis
Evaluating PK, Tolerability, and Safety of Rifapentine and Isoniazid in Pregnant and Postpartum Women
The purpose of this study was to evaluate the pharmacokinetics (PK), tolerability, and safety of once-weekly doses of rifapentine (RPT) and isoniazid (INH) in HIV-1-infected and HIV-1-uninfected pregnant and postpartum women with…
- Trial name
- NCT02651259
- Testing
- Rifapentine (RPT), Isoniazid (INH), Pyridoxine (vitamin B6)
- Where
- 5 sites in Haiti, Kenya and 3 more
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV-1 Infection
Three Chemo Regimens as an Adjunct to ART for Treatment of Advanced AIDS-KS
This study was done to compare the safety and efficacy of three combination treatments for Kaposi's Sarcoma (KS) and AIDS: 1. Etoposide (ET) plus co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF)…
- Trial name
- NCT01435018
- Testing
- Etoposide (ET), Bleomycin and Vincristine (BV), Paclitaxel (PTX)
- Where
- 11 sites in Brazil, Kenya and 4 more
- Volunteers
- 334 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
HIV Infections
Evaluating the Safety, Tolerability, and Pharmacokinetics of an Investigational, Injectable HIV Medicine (GSK1265744) in HIV-Uninfected Adults
This study will evaluate the safety, tolerability, and pharmacokinetics (which is how the body interacts with drugs) of an investigational, injectable HIV medicine (GSK1265744) in healthy, HIV-uninfected adults.
- Trial name
- NCT02178800
- Testing
- GSK1265744 Tablets, Injectable GSK1265744
- Where
- 8 sites in United States, Brazil and 2 more
- Volunteers
- 199 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Positive, Malnourished
IMPAACT P1092: Steady State PK in Malnourished HIV Infected Children
Children living with HIV from sub-Saharan Africa often present with severe malnutrition. In severe malnutrition, metabolic and/or gut structural derangement may lead to inadequate antiretroviral (ARV) absorption and/or erratic…
- Trial name
- NCT01818258
- Testing
- ZDV+3TC+LPV/r
- Where
- 5 sites in Malawi, Tanzania and 2 more
- Volunteers
- 52 people
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group