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This is a pilot study investigating the safety of Doravirine (DOR) in combination with Lamivudine (3TC) and Tenofovir Disoproxil Fumarate (TDF) administered over 48 weeks in women of reproductive potential living with HIV-1 switched from Efavirenz or Dolutegravir-based antiretroviral therapy on metabolic and neuropsychiatric outcomes.
This is a pilot, open label, single-arm, single centre, phase 3, switch study exploring the safety of of Doravirine (DOR) in combination with Lamivudine (3TC) and Tenofovir Disoproxil Fumarate (TDF) administered over 48 weeks in women of reproductive potential living with HIV-1 switched from Efavirenz or Dolutegravir-based antiretroviral therapy. The metabolic and neuropsychiatric outcomes among women (and their infants) in a representative African female population of reproductive potential will be investigated.
Approximately 100 women aged between 18 and 49 years old 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delstrigo | Experimental | Once-daily, fixed-dose combination of doravirine 100 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg (DOR/3TC/TDF). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate | Drug | DOR/3TC/TDF 100/300/300 mg once daily fixed-dose combination switched from either EFV/TDF/FTC or DTG/TDF/3TC |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of participants with neuropsychiatric adverse events (AEs) | The proportion of participants with neuropsychiatric adverse events (AEs) in 3 pre-specified categories (dizziness, sleep disorders/ disturbances, and altered sensorium) at Week 48 | 48 weeks |
| Changes in fasting lipids from baseline to Week 48 | Changes in fasting lipids from baseline to Week 48 assessed using lipid profile blood test | 48 weeks |
| Changes in weight from baseline to Week 48 | Changes in weight from baseline to Week 48 assessed | 48 weeks |
| Changes in body mass index from baseline to Week 48 | Changes in body mass index from baseline to Week 48 assessed | 48 weeks |
| Changes in glucose from baseline to Week 48 | Changes in glucose from baseline to Week 48 assessed using blood test | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of participants with detectable plasma HIV-1 RNA levels (≥ 50 copies/mL) | The proportion of participants with detectable plasma HIV-1 RNA levels (≥ 50 copies/mL) at weeks 24 and 48 | At week 24, 48 |
| The proportion of participants with neuropsychiatric adverse events (AEs) in 3 pre-specified categories |
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Inclusion Criteria:
Exclusion Criteria:
Female HIV-positive participants of reproductive potential age
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| Name | Affiliation | Role |
|---|---|---|
| Simiso Sokhela | Ezintsha, a subdivision of Wits Reproductive Health and HIV Institute (Wits RHI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charlotte Maxeke Johannesburg Academic Hospital | Johannesburg | Gauteng | 2196 | South Africa | ||
| Sunnyside Office Park |
The data that will be shared is all of the individual participant data collected during the trial, after deidentification.The data that will be shared is all of the individual participant data collected during the trial, after identification. The data that will be shared is all of the individual participant data collected during the trial, after deidentification.
Immediately following publication
Anyone who wishes to access the data
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 18, 2023 | |
| Reset | Mar 21, 2024 | |
| Release | Jun 12, 2024 | |
| Reset | Sep 25, 2024 | |
| Release | Mar 25, 2025 | |
| Reset | Apr 10, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 18, 2023 | Mar 21, 2024 | |||
| Jun 12, 2024 |
| ID | Term |
|---|---|
| C000592662 | doravirine |
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The proportion of participants with neuropsychiatric adverse events (AEs) in 3 pre-specified categories (dizziness, sleep disorders/ disturbances, and altered sensorium) at Week 24 |
| 24 weeks |
| Changes in glucose from baseline to week 24 | Changes in glucose from baseline to Week 24 using blood test | 24 weeks |
| Changes in fasting lipids from baseline to week 24 | Changes in fasting lipids from baseline to Week 24 using lipid profile blood test | 24 weeks |
| Changes in weight and from baseline to week 24 | Changes in weight from baseline to Week 24 | 24 weeks |
| Changes in body mass index from baseline to week 24 | Changes in body mass index from baseline to Week 24 | 24 weeks |
| The proportion of infants evaluated for HIV-positive tests using HIV DNA polymerase chain reaction test (PCR) | The proportion of infants evaluated for HIV-positive tests using HIV DNA polymerase chain reaction test (PCR) | 48 weeks |
| Changes in quality of life from baseline | Changes in quality of life from baseline to Weeks 24 and 48 measured using a traditional clinical, validated quality of life questionairre. Higher scores mean a better outcome | At weeks 24, 48 |
| Median adherence by each adherence measure | Median adherence by each adherence measure at Weeks 24 and 48 using a validated adherence questionairre | At weeks 24, 48 |
| Emergence of antiretroviral resistance mutations in participants with virological failure | Evaluating the number of antiretroviral resistance mutations that emerge in participants with virological failure | 48 weeks |
| Johannesburg |
| Gauteng |
| South Africa |
| Sep 25, 2024 |
| Mar 25, 2025 | Apr 10, 2025 |