Human Immunodeficiency Virus Clinical Trial
Official title:
Nucleosides And Darunavir/Dolutegravir In Africa (NADIA): a Randomised Controlled Trial of Darunavir Versus Dolutegravir and Tenofovir Versus Zidovudine in Second-line Antiretroviral Therapy Regimens for the Public Health Approach in Sub-Saharan Africa
This trial evaluates options for second-line antiretroviral therapy in patients failing on a
non-nucleoside reverse transcriptase inhibitor (NNRTI) and tenofovir (TDF)-based first-line
regimen in the setting of the public health approach in sub-Saharan Africa (with assumed
substantial nucleoside reverse transcriptase inhibitor (NRTI) cross-resistance). The trial
tests two hypotheses. Firstly that a regimen of dolutegravir (DTG) with two NRTIs is
non-inferior to a regimen of ritonavir-boosted darunavir (DRV/r) with two NRTIs. Secondly
that continuing an NRTI regimen of TDF and lamivudine (3TC) is non-inferior to switching to
zidovudine (ZDV) and 3TC.
The trial is a parallel group, open-label, multi-centre, factorial (2X2) randomised,
controlled trial. Patients will be randomised to either DTG or DRV/r with a second
randomisation to ZDV and 3TC or TDF and 3TC. Treatment efficacy will be monitored by testing
viral load (VL). Analyses will compare DRV/r with DTG; and ZDV/3TC with TDF/3TC by intention
to treat analysis on the primary outcome parameter of plasma VL below 400 copies/ml at 48
weeks. Trial follow-up will continue to 96 weeks.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03516318 -
Using Social Media to Improve ART Retention and Treatment Outcomes Among YLHIV in Nigeria
|
N/A | |
| Completed |
NCT04653194 -
Efficacy of BIC/F/TAF Versus Standard of Care in the Treatment of New HIV Infection Diagnoses in the Context of 'Test and Treat'
|
Phase 3 | |
| Completed |
NCT01792570 -
DRV/r + RPV QD: Efficacy and Toxicity Reduction
|
Phase 3 | |
| Active, not recruiting |
NCT04826562 -
Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND)
|
Phase 4 | |
| Completed |
NCT04191967 -
Thermocoagulation for Treatment of Precancerous Cervical Lesions
|
N/A | |
| Completed |
NCT02812329 -
Intervention to Encourage HIV Testing and Counseling Among Adolescents
|
Phase 1 | |
| Completed |
NCT02919306 -
Safety and Efficacy Study of Vaccine Schedule With Ad26.Mos.HIV and MVA-Mosaic in Human Immunodeficiency Virus (HIV)-Infected Adults
|
Phase 1/Phase 2 | |
| Completed |
NCT02516930 -
A Non-inferiority Randomized Controlled Trial to Evaluate Promoting Condom Use Among MSM and Transgender Individuals in China
|
N/A | |
| Completed |
NCT02651376 -
Safety and Efficacy of Allogenic Adoptive Immune Therapy for Advanced AIDS Patients
|
Phase 1/Phase 2 | |
| Recruiting |
NCT02392884 -
HIV Medication Adherence in Underserved Populations
|
N/A | |
| Completed |
NCT01944371 -
Short-term Disulfiram Administration to Reverse Latent HIV Infection: a Dose Escalation Study
|
Phase 1/Phase 2 | |
| Recruiting |
NCT01778374 -
Mater-Bronx Rapid HIV Testing Project.
|
N/A | |
| Completed |
NCT00914225 -
Effect of Bednets and a Water Purification Device on HIV Disease Progression Among ART naïve Patients in Kenya
|
N/A | |
| Completed |
NCT01076179 -
Kaletra in Combination With Antiretroviral Agents
|
N/A | |
| Completed |
NCT01460433 -
Problems With Immune Recovery in the Gut Tissue
|
N/A | |
| Completed |
NCT01490346 -
Tissue Drug Levels of HIV Medications
|
N/A | |
| Completed |
NCT00317460 -
Buprenorphine and Integrated HIV Care
|
Phase 4 | |
| Terminated |
NCT04240210 -
Integrase Regimen Switch to Symtuza to Increase Tolerability/Adherence (SYMita)
|
Phase 4 | |
| Active, not recruiting |
NCT04704336 -
Integration of Hypertension Management Into HIV Care in Nigeria
|
N/A | |
| Completed |
NCT03254277 -
3BNC117-LS First-in-Human Phase 1 Study
|
Phase 1 |