Clinical trials: Infections, Human Immunodeficiency Virus and Tuberculosis
Drug Addiction, HIV/AIDS
Cohort Study on People Who Inject Drugs in Senegal
The main purpose of the CoDISEN cohort study is to propose a model of prevention and care for HIV and viral hepatitis adapted to the needs of people who inject drugs (PWID) in Dakar, Senegal.
- Conditions
- Drug Addiction, HIV/AIDS, Hepatitis C, Chronic, Hepatitis C, Acute
- Trial name
- CoDISEN (NCT03459768)
- Where
- Senegal
- Volunteers
- 208 people
- Sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
HIV Infections, Tuberculosis
Nevirapine Drug Levels in HIV Positive Patients Also Receiving Rifampicin for Tuberculosis
Triomune is the most commonly prescribed treatment for HIV infection in Uganda. Triomune is manufactured by a generic drug company and consists of three drugs combined in a single pill given twice daily (stavudine 30mg plus…
- Trial name
- NCT00617643
- Testing
- Nevirapine without dose escalation, Nevirapine initiation with dose escalation
- Where
- Uganda
- Volunteers
- 18 people
- Sponsor
- Makerere University
Tuberculosis, HIV I Infection
ThiPhiSA: New Pathways to Prevention From Community TB Screening in South Africa
This study will compare community-delivered, multi-month dispensing of tuberculosis preventive therapy (TPT) to standard-of-care clinic-based TPT delivery in a population of South African adults who are recommended to receive TB…
- Trial name
- ThiPhiSA (NCT06214910)
- Testing
- Community-delivered TB preventive therapy (TPT) - 3 months weekly isoniazid plus rifapentine (3HP), Clinic-link TPT
- Where
- South Africa
- Volunteers
- 301 people
- Sponsor
- University of Washington
Pediatric HIV Infection, Tuberculosis Infection
Dolutegravir Pharmacokinetics Among HIV/TB Coinfected Children Receiving Standard and High-dose Rifampicin
Tuberculosis (TB) is the leading cause of death among children with HIV, yet insufficient data are available on the pharmacokinetics of newer HIV/TB cotreatment strategies in children.
- Trial name
- NCT05069688
- Testing
- rifampicin
- Where
- Nigeria
- Volunteers
- 20 people
- Sponsor
- Brigham and Women's Hospital
HIV Infections, Tuberculosis
Pharmacokinetics of Rifabutin Combined With Antiretroviral Therapy in Patients With TB/HIV Co-infection in Vietnam
The overall aim of the project is to evaluate rifabutin (RBT) as a replacement for rifampicin (RMP), for the combined treatment of tuberculosis and HIV infection.
- Trial name
- NCT00651066
- Testing
- rifabutin in combination with lopinavir boosted by ritonavir - dosing schedule 1, rifabutin in combination with lopinavir boosted by ritonavir - dosing schedule 2
- Where
- Vietnam
- Volunteers
- 47 people
- Sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
Tuberculosis
Ultra Curto (Ultra Short) TB Prevention Therapy
To compare treatment success (adherence and completion of treatment) and safety of 1HP with 3HP in HIV-uninfected adults and adolescents at increased risk of TB.
- Trial name
- NCT04703075
- Testing
- Rifapentine 600 mg and INH 300 mg, Rifapentine 900 mg and INH 900 mg
- Where
- 2 sites in Brazil
- Volunteers
- 531 people
- Sponsor
- Johns Hopkins University
HIV Infections, Tuberculosis
Raltegravir + Lamivudine/Abacavir in HIV/Tuberculosis Co-Infected Patients
The study will investigate whether combination antiretroviral therapy of raltegravir and 3TC/ABC is effective and safe to use in tuberculosis (TB)/HIV co-infected adults receiving rifabutin-containing, first-line antituberculous…
- Trial name
- NCT01059422
- Testing
- Raltegravir; Abacavir/Lamivudine
- Where
- Russia
- Volunteers
- 10 people
- Sponsor
- Central Institute of Epidemiology, Moscow, Russia
Human Immunodeficiency Virus (HIV) Infection
Same-day Versus Rapid ART Initiation in HIV-positive Individuals Presenting With Symptoms of Tuberculosis
SaDAPT is a pragmatic, randomized, therapeutic-use trial comparing two approaches ("ART first" versus "TB results first") for the timing of ART initiation in PLHIV with presumptive TB, but no signs of central nervous system (CNS)…
- Trial name
- SaDAPT (NCT05452616)
- Testing
- ART first- Therapeutic use trial, TB results first- Therapeutic use trial
- Where
- 2 sites in Lesotho, Malawi
- Volunteers
- 610 people
- Sponsor
- University Hospital, Basel, Switzerland
Tuberculosis
Isoniazid Prophylaxis With Concomitant Cotrimoxazole in HIV-infected Children
The study involves use of isoniazid and cotrimoxazole as strategies for preventing infections in HIV-infected children and reducing mortality.
- Trial name
- NCT00330304
- Testing
- Isoniazid, Cotrimoxazole
- Where
- 2 sites in South Africa
- Volunteers
- 450 people
- Sponsor
- University of Cape Town
HIV/AIDS
Swaziland HIV Incidence Measurement Survey 2
The second Swaziland HIV Incidence Measurement Survey (SHIMS 2, 2016), is a population based HIV Impact Assessment (PHIA) that will assess the prevalence of key human immunodeficiency virus (HIV)-related health indicators.
- Trial name
- SHIMS2 (NCT04117984)
- Where
- Eswatini
- Volunteers
- 15,429 people, healthy volunteers welcome
- Sponsor
- Columbia University
HIV Infection, Tuberculosis Infection
Micro RNA as Prediction and/or Prognostic Markers of IRIS in TB-HIV Co-infected Patients
The role of miRNAs in HIV disease is yet to be completely defined. Host miRNAs target certain HIV genes, thus can affect HIV replication and participate in viral control.
- Trial name
- miRNA (NCT03941210)
- Testing
- Detection of molecular Biomarkers
- Where
- Cambodia
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- ANRS, Emerging Infectious Diseases
Tuberculosis
A Phase I Randomized Placebo-Controlled, Double-Blind Study to Evaluate Safety and Immunogenicity of AERAS-404 Administered as Different Amounts of Antigen and Adjuvant Combinations in HIV-Negative BCG-Vaccinated Adults Without Evidence of Tuberculosis Infection
Phase I, randomized, double blinded, Placebo-controlled, immunogenicity and dose-range finding study of AERAS-404 in Bacille Calmette-Guerin (BCG) healthy adult male and sterile females.
- Trial name
- NCT02066428
- Testing
- AERAS-404
- Where
- Sweden
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Aeras
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
Non-tuberculous Mycobacterial Diseases, Tuberculosis
Safety And Efficacy Of Rifabutin In HIV Patients
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors…
- Conditions
- Non-tuberculous Mycobacterial Diseases, Tuberculosis, Inhibition of Disseminated Mycobacterium Avium Complex Disease Associated With HIV Infections
- Trial name
- NCT00810446
- Testing
- rifabutin
- Volunteers
- 72 people
- Sponsor
- Pfizer
Pulmonary Tuberculosis, Tuberculosis Diagnosis
Diagnostic Accuracy of CAD4TB and C-reactive Protein Assay as Triage Tests for Pulmonary Tuberculosis
In the TB TRIAGE+ ACCURACY study, the accuracy of the following products will be determined: CAD4TB (Delft Imaging System, NL), a digital chest x-ray analysis software Afinion CRP assay (Alere Afinion, USA), which detects a…
- Conditions
- Pulmonary Tuberculosis, Tuberculosis Diagnosis, Covid-19, HIV
- Trial name
- TB TRIAGE+ (NCT04666311)
- Testing
- Accuracy of CAD4TB and Afinion CRP assay for pulmonary TB, CAD4COVID+WBC and COVID-19 RDT for SARS-CoV-2 infection
- Where
- 2 sites in Lesotho, South Africa
- Volunteers
- 1,400 people
- Sponsor
- Klaus Reither
Tuberculosis
TBTC Study 25PK: Intensive Pharmacokinetic Study of Three Doses of Rifapentine and 25-Desacetyl Rifapentine
Primary objective: To compare the pharmacokinetics of rifapentine and 25-desacetyl rifapentine at three different doses: 600 mg, 900 mg, and 1200 mg.
- Trial name
- NCT00023387
- Testing
- Rifapentine, 25-desacetyl Rifapentine, Isoniazid
- Where
- 23 sites in United States, Canada
- Volunteers
- 36 people
- Sponsor
- Centers for Disease Control and Prevention
Tuberculosis
Study of the Safety and Efficacy of the Subunit Recombinant Tuberculosis Vaccine GamTBvac
This study is a multicenter, double-blind, randomized, placebo-controlled Phase III trial designed to evaluate the efficacy and safety of the GamTBvac recombinant subunit tuberculosis vaccine for the prevention of active…
- Trial name
- NCT04975737
- Testing
- GamTBvac
- Where
- Russia
- Volunteers
- 9,500 people, healthy volunteers welcome
- Sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
HIV Infections, Tuberculosis
A Study to Determine the Best Dose of Antivirals in Patients With Both TB and HIV
Because drugs used to treat TB can reduce the amount of the anti-HIV drugs that reach the sites where the virus is located, this study is designed to see whether it is necessary to use higher doses of antiviral (anti-HIV) drugs…
- Trial name
- OPTI-NNRTI (NCT00523458)
- Testing
- efavirenz or nevirapine
- Where
- Brazil
- Volunteers
- 5 people
- Sponsor
- Stanford University
HIV Infection, Tuberculosis
Prevention of Early Mortality by Presumptive Tuberculosis (TB) Treatment
This study investigates the prevention of early mortality in patients initiating antiretroviral therapy (ART) in sub-Saharan Africa where 79% of the co-infected cases of TB reside.
- Trial name
- PrOMPT (NCT01417988)
- Testing
- Experimental: Empiric TB treatment, ART only arm
- Where
- 3 sites in Gabon, Mozambique and 1 more
- Volunteers
- 44 people
- Sponsor
- Prof JMA Lange
Sepsis, Tuberculosis
STeroids and Enhanced Spectrum Antibiotics for the Treatment of Patients in Africa With Refractory Sepsis
Sepsis, a life-threatening condition due to a dysregulated response to infection, is the leading cause of global mortality and is frequently driven by tuberculosis (TB) and drug-resistant bacteria in sub-Saharan Africa…
- Trial name
- STARS (NCT07332325)
- Testing
- Hydrocortisone administration, Expanded antimicrobial therapy
- Where
- 4 sites in Tanzania, Uganda
- Volunteers
- 344 people
- Sponsor
- University of Virginia