Phase 2
Completed N=123
Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011)
Source: ClinicalTrials.gov NCT03272347 ↗Enrolled (actual)
123
Serious AEs
8.1%
Results posted
Apr 2022
Primary outcomePrimary: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 24 — 93.1; 100.0; 90.3; 90.3 Percentage of participants
Summary
This study will evaluate the safety, tolerability, antiretroviral activity, and pharmacokinetics of 3 doses of islatravir (MK-8591) in combination with doravirine (DOR) and lamivudine (3TC) administered to antiretroviral treatment-naïve adult participants with human immunodeficiency virus type 1 (HIV-1) infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 24 |
93.1; 100.0; 90.3; 90.3 | — |
| PRIMARY Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 |
89.7; 90.0; 77.4; 83.9 | — |
| PRIMARY Number of Participants Experiencing Adverse Events (AEs) up to Week 144 |
26; 27; 24; 27 | — |
| PRIMARY Number of Participants Discontinuing Study Drug Due to AEs up to Week 144 |
1; 0; 2; 1 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA <50 Copies/mL up to 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen |
86.2; 90.0; 88.9; 96.4 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA <50 Copies/mL up to 48 Weeks After 3TC and Placebo Are Discontinued From the Regimen |
62.1; 56.7; 59.3; 60.7 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA <50 Copies/mL up to 48 Weeks After Starting Open-label Doravirine/Islatravir Regimen (Part 4) |
85.1; 95.5 | — |
| SECONDARY Change From Baseline in Mature T-helper (CD4+ T)-Cell Count at Week 24 |
220.5; 192.8; 142.9; 142.1 | — |
| SECONDARY Change From Baseline in CD4+ T-cell Count at Week 48 |
182.0; 183.0; 100.7; 181.4 | — |
| SECONDARY Change From Baseline in CD4+ T-cell Count at Week 96 |
243.4; 161.3; 136.5; 268.9 | — |
| SECONDARY Change From Baseline in CD4+ T-cell Count at Week 144 |
204.4; 209.0; 162.9; 270.0 | — |
| SECONDARY Change From Baseline in CD4+ T-cell Count at Week 192 (Part 4) |
3.8; -3.4 | — |
| SECONDARY Number of Participants Experiencing AEs Through 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen |
18; 20; 14; 16 | — |
| SECONDARY Number of Participants Discontinuing Study Drug Due to AEs Through 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen |
0; 0; 2; 1 | — |
| SECONDARY Number of Participants Experiencing AEs From Week 96 Through Study Duration |
12; 19; 11; 12; 36; 14 | — |
| SECONDARY Number of Participants Discontinuing Study Drug Due to AEs From Week 96 Through Study Duration |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Experiencing AEs During Open Label Doravirine/Islatravir Treatment After Week 144 up to Week 192 (Part 4) |
36; 14 | — |
| SECONDARY Number of Participants Discontinuing Study Drug Due to AEs During Open Label Doravirine/Islatravir Treatment After Week 144 up to Week 192 (Part 4) |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Has HIV-1 infection
- Is naïve to anti-retroviral therapy (ART).
- Is clinically stable, with no signs or symptoms of acute infection, at the time of entry into the study
- Female is not pregnant, not breastfeeding, not a woman of childbearing potential (WOCBP); but if WOCBP agrees to follow the contraceptive guidance
- All participants, male and female, agree to use barrier methods of contraception when engaged in any sexual activity during treatment and for 6 weeks following treatment.
Exclusion Criteria
- Is a user of recreational or illicit drugs or has had a history of drug or alcohol abuse or dependence that may interfere with trial participation
- Has significant hypersensitivity or other contraindication to any of the components of the study drugs
- Has a history of malignancy ≤5 years prior
- Female expects to donate eggs at any time during the study
- Is breastfeeding or expecting to conceive
- A WOCBP who has a positive urine pregnancy test on Day 1 before the first dose of study treatment
- Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1
- Has used systemic immunosuppressive therapy or immune modulators within 30 days prior to treatment in this study or is anticipated to need them during the course of the study
- Requires any of the following prohibited medications: Carbamazepine, Phenobarbital, Phenytoin, Rifabutin, Rifampin, Herbal remedies, St. John's Wort, Modafinil, Bosentan, Nafcillin, Pentostatin
- Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days of signing informed consent to participate in this current trial
- Has a documented or known virologic resistance to any approved HIV-1 reverse transcriptase inhibitor, protease inhibitor, integrase inhibitor
- Has active hepatitis C virus (HCV) coinfection defined as detectable HCV RNA or HBV co-infection defined as hepatitis B surface antigen [HBsAg]-positive
- Has a current (active) diagnosis of acute hepatitis due to any cause
- Has previously been randomized in a study and received islatravir (MK-8591), DOR, Doravirine, Tenofovir, Lamivudine, or 3TC.
Data sourced from ClinicalTrials.gov (NCT03272347). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.