ADORE: Efficacy of DORavirine in Adults Living With HIV Experiencing Virological Failure on First-line Efavirenz-based Antiretroviral Therapy With NNRTI Resistance (ADORE)
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|ClinicalTrials.gov Identifier: NCT04429152|
Recruitment Status : Recruiting
First Posted : June 12, 2020
Last Update Posted : November 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|HIV-1-infection||Drug: Doravirine/Lamivudine/Tenofovir||Phase 3|
This is a single-arm, phase 3 pilot study investigating the efficacy of Doravirine (DOR) in combination with Lamivudine (3TC) and Tenofovir Disoproxil Fumarate (TDF) administered over 48 weeks in adults living with HIV-1 experiencing virological failure on first-line Efavirenz-based antiretroviral therapy with non-nucleoside reverse transcriptase inhibitor resistance.
Approximately 25 male and female participants 18 years and older infected with HIV-1 and experiencing virological failure on efavirenz-based ART will be administered a once-daily, fixed-dose combination of doravirine 100 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg (DOR/3TC/TDF). The study includes screening and baseline visits, 4 study visits from Week 4 to Week 36, and an end of study visit at Week 48.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||ADORE: A Single-arm, Phase 3, Pilot Study Investigating the Efficacy of Doravirine in Adults Living With HIV Experiencing Virological Failure on First-line Efavirenz-based Antiretroviral Therapy With Non-nucleoside Reverse Transcriptase Inhibitor Resistance|
|Estimated Study Start Date :||November 10, 2020|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Once-daily, fixed-dose combination of doravirine 100 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg (DOR/3TC/TDF).
DOR/3TC/TDF 100/300/300 mg once daily fixed-dose combination
Other Name: Delstrigo
- Proportion of participants with undetectable plasma HIV-1 RNA levels (<50 copies/mL) at week 24 [ Time Frame: 24 weeks ]The proportion of participants with undetectable plasma HIV-1 RNA levels at Week 24 will be recorded.
- Proportion of patients with undetectable plasma HIV-1 RNA levels (<50 copies/mL) at weeks 4, 12 and 48 [ Time Frame: At week 4, 12, 48 ]Evaluation of viral suppression by recording the proportion of patients with undetectable plasma HIV-1 RNA levels (<50 copies/mL) at weeks 4, 12 and 48
- Change from baseline in plasma CD4 levels at weeks 24 and 48 [ Time Frame: At week 24, 48 ]Evaluation of changes in CD4 count from baseline recorded at weeks 24 and 48.
- Emergence of antiretroviral resistance mutations in participants with virological failure [ Time Frame: 48 weeks ]Evaluation of the number of antiretroviral resistance mutations that emerge in participants with virological failure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04429152
|Contact: Simiso Sokhela, MBBChemail@example.com|
|Contact: Bronwyn Bosch, MBBChfirstname.lastname@example.org|
|Charlotte Maxeke Johannesburg Academic Hospital||Recruiting|
|Johannesburg, Gauteng, South Africa, 2196|
|Contact: Natasha Arulappan +27113585542 email@example.com|
|Contact: Nonkululeko Mashabane, BPharm +27113585543|
|Sunnyside Office Park||Not yet recruiting|
|Johannesburg, Gauteng, South Africa|
|Contact: Bronwyn Bosch, MBBCh +27113585300 firstname.lastname@example.org|
|Contact: Godspower Akpomiemie, MPH +2711358 5370 email@example.com|
|Wits RHI Yeoville Clinic||Not yet recruiting|
|Johannesburg, Gauteng, South Africa|
|Contact: Simiso Sokhela, MBBCh +27113585500 firstname.lastname@example.org|
|Contact: Nonkululeko Mashabane, BPharm +27113585543 email@example.com|
|Principal Investigator: Simiso Sokhela, MBBCh|
|Sub-Investigator: Nomathemba Chandiwana, MBBCh|
|Principal Investigator:||Simiso Sokhela, MBBCh||Ezintsha, a subdivision of Wits Reproductive Health and HIV Institute (Wits RHI)|