HIV-1 Infection Clinical Trial
Official title:
A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in Participants With HIV-1 Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)
| Verified date | October 2023 |
| Source | Merck Sharp & Dohme LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The primary objectives of this study are to evaluate the antiretroviral activity of a switch to DOR/ISL compared with continued BIC/FTC/TAF at Week 48; and to evaluate the safety and tolerability of a switch to DOR/ISL compared with continued BIC/FTC/TAF, through Week 48. The primary hypotheses are that (1) DOR/ISL is non-inferior to continued BIC/FTC/TAF, as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48, with a margin of 4 percentage points used to define non-inferiority; and (2) DOR/ISL is superior to BIC/FTC/TAF, as assessed by the percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48.
| Status | Active, not recruiting |
| Enrollment | 501 |
| Est. completion date | October 15, 2025 |
| Est. primary completion date | November 13, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | The key inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: - Is HIV-1 positive with plasma HIV-1 RNA <50 copies/mL - Has been receiving BIC/FTC/TAF therapy with documented viral suppression (HIV-1 RNA <50 copies/mL) for =3 consecutive months prior to providing documented informed consent and has no history of prior virologic treatment failure on any past or current regimen - Female is not a participant of childbearing potential (POCBP); or if a participant of childbearing potential, not pregnant or breastfeeding, and is willing to use an acceptable contraceptive method or abstain from heterosexual intercourse for study duration Exclusion Criteria: - Has HIV-2 infection - Has a diagnosis of an active acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 30 days prior to screening - Has active hepatitis B virus (HBV) infection - Has chronic hepatitis C virus (HCV) infection with laboratory values consistent with cirrhosis - Has a history of malignancy =5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma - Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or strong and moderate cytochrome P450 3A (CYP3A ) inducers - Has a documented or known virologic resistance to DOR - Has taken long-acting HIV therapy at any time (e.g., cabotegravir, lenacapavir) - Is currently participating in or has participated in a clinical study and received (or is receiving) an investigational compound or device from 45 days prior to Day 1 through the study treatment period except those currently enrolled in the comparator arm of an ongoing DOR/ISL study |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Holdsworth House Medical Practice - Brisbane ( Site 6201) | Brisbane | Queensland |
| Australia | Royal Brisbane and Women's Hospital-Infectious Diseases Research ( Site 6204) | Brisbane | Queensland |
| Australia | Holdsworth House Medical Practice ( Site 6200) | Darlinghurst | New South Wales |
| Australia | Prahran Market Clinic ( Site 6202) | Melbourne | Victoria |
| Australia | St Vincent's Hospital-IBAC ( Site 6203) | Sydney | New South Wales |
| Chile | Clínica Universidad de Los Andes ( Site 2206) | Santiago | Region M. De Santiago |
| Chile | Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 2200) | Santiago | Region M. De Santiago |
| Chile | Clinica Universidad Catolica del Maule ( Site 2204) | Talca | Maule |
| Chile | Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 2205) | Temuco | Araucania |
| Israel | Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 4801) | Haifa | |
| Israel | Hadassah Medical Center-Infecious Disease ( Site 4802) | Jerusalem | |
| Israel | Sheba Medical Center-HIV unit ( Site 4803) | Ramat Gan | |
| Israel | Sourasky Medical Center ( Site 4804) | Tel Aviv | |
| Japan | National Hospital Organization Nagoya Medical Center ( Site 6603) | Nagoya | Aichi |
| Japan | National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 66 | Osaka | |
| Japan | Center Hospital of the National Center for Global Health and Medicine ( Site 6601) | Shinjyuku-ku | Tokyo |
| United Kingdom | Queen Elizabeth Hospital Birmingham ( Site 5809) | Birmingham | England |
| United Kingdom | Southmead Hospital ( Site 5805) | Bristol | Bristol, City Of |
| United Kingdom | University Hospital of Wales ( Site 5803) | Cardiff | Wales |
| United Kingdom | Royal Liverpool University Hospital ( Site 5812) | Liverpool | England |
| United Kingdom | Guy's & St Thomas' NHS Foundation Trust ( Site 5808) | London | London, City Of |
| United Kingdom | Royal Free Hospital ( Site 5801) | London | England |
| United Kingdom | Royal London Hospital ( Site 5800) | London | England |
| United Kingdom | The Mortimer Market Centre for Sexual Health and HIV Research ( Site 5810) | London | London, City Of |
| United Kingdom | Royal Berkshire Hospital ( Site 5813) | Reading | |
| United States | Central Texas Clinical Research ( Site 1413) | Austin | Texas |
| United States | St Hope Foundation ( Site 1410) | Bellaire | Texas |
| United States | Be Well Medical Center ( Site 1408) | Berkley | Michigan |
| United States | Pacific Oaks Medical Group ( Site 1400) | Beverly Hills | California |
| United States | AccessHealth MA ( Site 1419) | Boston | Massachusetts |
| United States | North Texas Infectious Diseases Consultants, P.A ( Site 1404) | Dallas | Texas |
| United States | Prism Health North Texas, Oak Cliff Health Center ( Site 1409) | Dallas | Texas |
| United States | Infectious Disease Specialists of Atlanta ( Site 1403) | Decatur | Georgia |
| United States | Therafirst Medical Center ( Site 1402) | Fort Lauderdale | Florida |
| United States | Midway Immunology and Research Center ( Site 1401) | Fort Pierce | Florida |
| United States | Texas Centers for Infectious Disease Associates ( Site 1406) | Fort Worth | Texas |
| United States | Regional Center for Infectious Disease Research ( Site 1435) | Greensboro | North Carolina |
| United States | The Crofoot Research Center ( Site 1424) | Houston | Texas |
| United States | KC CARE Health Center-Clinical Trials ( Site 1422) | Kansas City | Missouri |
| United States | Las Vegas Research Center ( Site 1436) | Las Vegas | Nevada |
| United States | DCOL Center for Clinical Research ( Site 1415) | Longview | Texas |
| United States | Mills Clinical Research ( Site 1433) | Los Angeles | California |
| United States | Ruane Clinical Research Group, Inc ( Site 1414) | Los Angeles | California |
| United States | Mercer University, Department of Internal Medicine ( Site 1411) | Macon | Georgia |
| United States | AHF The Kinder Medical Group ( Site 1426) | Miami | Florida |
| United States | Orlando Immunology Center ( Site 1407) | Orlando | Florida |
| United States | Pueblo Family Physicians ( Site 1425) | Phoenix | Arizona |
| United States | Whitman-Walker Institute ( Site 1431) | Washington | District of Columbia |
| United States | Triple O Research Institute, P.A ( Site 1417) | West Palm Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Australia, Chile, Israel, Japan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of participants with HIV-1 RNA =50 copies/mL at Week 48 | Percentage of participants with HIV-1 RNA =50 copies/mL at Week 48 will be reported. | Week 48 | |
| Primary | Percentage of participants who experience adverse events (AEs) through Week 48 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to Week 48 | |
| Primary | Percentage of participants who discontinue study intervention due to AEs through Week 48 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to Week 48 | |
| Secondary | Percentage of participants with HIV-1 RNA =50 copies/mL at Week 96 | Percentage of participants with HIV-1 RNA =50 copies/mL at Week 96 will be reported. | Week 96 | |
| Secondary | Percentage of participants with HIV-1 RNA <200 copies/mL at Week 48 | Percentage of participants with HIV-1 RNA <200 copies/mL at Week 48 will be reported. | Week 48 | |
| Secondary | Percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 | Percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 will be reported. | Week 48 | |
| Secondary | Percentage of participants with HIV-1 RNA <200 copies/mL at Week 96 | Percentage of participants with HIV-1 RNA <200 copies/mL at Week 96 will be reported. | Week 96 | |
| Secondary | Percentage of participants with HIV-1 RNA <50 copies/mL at Week 96 | Percentage of participants with HIV-1 RNA <50 copies/mL at Week 96 will be reported. | Week 96 | |
| Secondary | Change from baseline in CD4+ T-cell count at Week 48 | Mean change from baseline at Day 1 in CD4+ T-cell count at Week 48 will be reported. | Baseline at Day 1 and Week 48 | |
| Secondary | Change from baseline in CD4+ T-cell count at Week 96 | Mean change from baseline at Day 1 in CD4+ T-cell count at Week 96 will be reported. | Baseline at Day 1 and Week 96 | |
| Secondary | Number of participants with viral drug resistance mutations at Week 48 | Number of participants with evidence of viral drug resistance-associated substitutions at Week 48 will be reported. | Week 48 | |
| Secondary | Number of participants with viral drug resistance mutations at Week 96 | Number of participants with evidence of viral drug resistance-associated substitutions at Week 96 will be reported. | Week 96 | |
| Secondary | Percentage of participants who experience AEs through study duration | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to Week 102 | |
| Secondary | Percentage of participants who discontinue study intervention due to AEs through study duration | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to Week 96 |
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