HIV Clinical Trial
— NEW-STRAT TBOfficial title:
Testing New Strategies for Patients Hospitalised With HIV-associated Disseminated Tuberculosis
The New Strat-TB trial is a superiority Phase III randomised control clinical trial with a 2X2 factorial design. The main aim of the study is to assess the efficacy and safety of high dose rifampicin and levofloxacin for 14 days in addition to standard TB therapy with or without steroids among adults hospitalized with HIV-associated disseminated tuberculosis. The investigators hypothesize that intensified treatment with increased rifampicin doses at 35 mg/kg plus levofloxacin will more rapidly reduce the mycobacterial load. The investigators also hypothesize that steroids will have an immune-modulatory effect and dampen the activation of the innate immune system. The investigators hypothesize that these two strategies will lead to improved survival in patients hospitalized with HIV-associated disseminated tuberculosis.
Status | Recruiting |
Enrollment | 732 |
Est. completion date | December 31, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Aged >18 - HIV infection - Disseminated TB confirmed by one or more of the following tests being positive 1. Lysed blood Xpert Ultra positive for MTB 2. Concentrated urine Xpert Ultra positive for MTB 3. Urine Alere LAM positive - Hospital clinical team made decision to initiate TB treatment Exclusion Criteria: - Pregnant or breastfeeding - Active or recent SARS-CoV-2 infection - TB treatment within the last 1 month or more than 2 doses of TB treatment - Rifampicin resistance - Neurological TB - Receiving corticosteroids or other immunosuppressive therapy - ALT >120 IU/L or total bilirubin >34 µmol/L - Plasma CrAg positive or cryptococcal meningitis - Current malignancy requiring active treatment (including any Kaposi sarcoma lesions) - Patients established on ART with Protease Inhibitor based regimen who cannot be switched to a dolutegravir based regimen - Diabetic ketoacidosis or Hyperosmolar Non-ketotic acidosis - Any condition in the opinion of the investigator for which participation would increase risk to the patient |
Country | Name | City | State |
---|---|---|---|
South Africa | Khayelitsha Hospital, c/o Steve Biko and Walter Sisulu Drives, Khayelitsha | Cape Town | Western Cape |
South Africa | Mitchells Plain Hospital, Mitchells PLain | Cape Town | Western Cape |
Lead Sponsor | Collaborator |
---|---|
University of Cape Town |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | All-cause mortality | 12 weeks | ||
Secondary | In-hospital mortality during index admission | 7 days | ||
Secondary | All-cause mortality | 2 and 24 weeks respectively |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06162897 -
Case Management Dyad
|
N/A | |
Completed |
NCT03999411 -
Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients
|
Phase 4 | |
Completed |
NCT02528773 -
Efficacy of ART to Interrupt HIV Transmission Networks
|
||
Active, not recruiting |
NCT05454839 -
Preferences for Services in a Patient's First Six Months on Antiretroviral Therapy for HIV in South Africa
|
||
Recruiting |
NCT05322629 -
Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women
|
N/A | |
Completed |
NCT02579135 -
Reducing HIV Risk Among Adolescents: Evaluating Project HEART
|
N/A | |
Active, not recruiting |
NCT01790373 -
Evaluating a Youth-Focused Economic Empowerment Approach to HIV Treatment Adherence
|
N/A | |
Not yet recruiting |
NCT06044792 -
The Influence of Primary HIV-1 Drug Resistance Mutations on Immune Reconstruction in PLWH
|
||
Completed |
NCT04039217 -
Antiretroviral Therapy (ART) Persistence in Different Body Compartments in HIV Negative MSM
|
Phase 4 | |
Active, not recruiting |
NCT04519970 -
Clinical Opportunities and Management to Exploit Biktarvy as Asynchronous Connection Key (COMEBACK)
|
N/A | |
Completed |
NCT04124536 -
Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women
|
N/A | |
Recruiting |
NCT05599581 -
Tu'Washindi RCT: Adolescent Girls in Kenya Taking Control of Their Health
|
N/A | |
Active, not recruiting |
NCT04588883 -
Strengthening Families Living With HIV in Kenya
|
N/A | |
Completed |
NCT02758093 -
Speed of Processing Training in Adults With HIV
|
N/A | |
Completed |
NCT02500446 -
Dolutegravir Impact on Residual Replication
|
Phase 4 | |
Completed |
NCT03805451 -
Life Steps for PrEP for Youth
|
N/A | |
Active, not recruiting |
NCT03902431 -
Translating the ABCS Into HIV Care
|
N/A | |
Completed |
NCT00729391 -
Women-Focused HIV Prevention in the Western Cape
|
Phase 2/Phase 3 | |
Recruiting |
NCT05736588 -
Elimisha HPV (Human Papillomavirus)
|
N/A | |
Recruiting |
NCT03589040 -
Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant
|
Phase 2 |