Trial record 1 of 1 for:
MK-8591A-052
A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052)
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| ClinicalTrials.gov Identifier: NCT05630755 |
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Recruitment Status :
Recruiting
First Posted : November 30, 2022
Last Update Posted : May 6, 2023
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Sponsor:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV-1 Infection | Drug: DOR/ISL Drug: BIC/FTC/TAF Drug: Placebo to BIC/FTC/TAF Drug: Placebo to DOR/ISL | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 501 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| 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) |
| Actual Study Start Date : | February 17, 2023 |
| Estimated Primary Completion Date : | September 16, 2024 |
| Estimated Study Completion Date : | August 15, 2025 |
| Arm | Intervention/treatment |
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Experimental: DOR/ISL and Placebo to BIC/FTC/TAF
Participants will receive DOR/ISL 100 mg/0.25 mg and Placebo to BIC/FTC/TAF once daily (QD) orally from day 1 to week 96.
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Drug: DOR/ISL
DOR/ISL 100 mg/0.25 mg oral tablets once daily
Other Name: MK-8591A Drug: Placebo to BIC/FTC/TAF 0 mg oral tablets once daily |
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Active Comparator: BIC/FTC/TAF and Placebo to DOR/ISL
Participants will receive BIC/FTC/TAF 50 mg/200 mg/25 mg and Placebo to DOR/ISL once daily (QD) orally from day 1 to week 96.
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Drug: BIC/FTC/TAF
BIC/FTC/TAF 50 mg/200 mg/25 mg oral tablets once daily Drug: Placebo to DOR/ISL 0 mg oral tablets once daily |
Primary Outcome Measures :
- Percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48 [ Time Frame: Week 48 ]Percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48 will be reported.
- Percentage of participants who experience adverse events (AEs) through Week 48 [ Time Frame: Up to 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.
- Percentage of participants who discontinue study intervention due to AEs through Week 48 [ Time Frame: Up to 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.
Secondary Outcome Measures :
- Percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96 [ Time Frame: Week 96 ]Percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96 will be reported.
- Percentage of participants with HIV-1 RNA <200 copies/mL at Week 48 [ Time Frame: Week 48 ]Percentage of participants with HIV-1 RNA <200 copies/mL at Week 48 will be reported.
- Percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 [ Time Frame: Week 48 ]Percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 will be reported.
- Percentage of participants with HIV-1 RNA <200 copies/mL at Week 96 [ Time Frame: Week 96 ]Percentage of participants with HIV-1 RNA <200 copies/mL at Week 96 will be reported.
- Percentage of participants with HIV-1 RNA <50 copies/mL at Week 96 [ Time Frame: Week 96 ]Percentage of participants with HIV-1 RNA <50 copies/mL at Week 96 will be reported.
- Change from baseline in CD4+ T-cell count at Week 48 [ Time Frame: Baseline at Day 1 and Week 48 ]Mean change from baseline at Day 1 in CD4+ T-cell count at Week 48 will be reported.
- Change from baseline in CD4+ T-cell count at Week 96 [ Time Frame: Baseline at Day 1 and Week 96 ]Mean change from baseline at Day 1 in CD4+ T-cell count at Week 96 will be reported.
- Number of participants with viral drug resistance mutations at Week 48 [ Time Frame: Week 48 ]Number of participants with evidence of viral drug resistance-associated substitutions at Week 48 will be reported.
- Number of participants with viral drug resistance mutations at Week 96 [ Time Frame: Week 96 ]Number of participants with evidence of viral drug resistance-associated substitutions at Week 96 will be reported.
- Percentage of participants who experience AEs through study duration [ Time Frame: Up to Week 102 ]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.
- Percentage of participants who discontinue study intervention due to AEs through study duration [ Time Frame: Up to Week 96 ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
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): NCT05630755
Contacts
| Contact: Toll Free Number | 1-888-577-8839 | Trialsites@merck.com |
Locations
Show 31 study locations
Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
| Study Director: | Medical Director | Merck Sharp & Dohme LLC |
| Responsible Party: | Merck Sharp & Dohme LLC |
| ClinicalTrials.gov Identifier: | NCT05630755 |
| Other Study ID Numbers: |
8591A-052 MK-8591A-052 ( Other Identifier: Merck ) 2022-502079-49-00 ( Registry Identifier: EU CT ) jRCT2051230003 ( Registry Identifier: jRCT ) |
| First Posted: | November 30, 2022 Key Record Dates |
| Last Update Posted: | May 6, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf |
| URL: | http://engagezone.msd.com/ds_documentation.php |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Islatravir Antiviral Agents Anti-Infective Agents Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Anti-Retroviral Agents |