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Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011)
Phase 2 trial testing Islatravir in HIV-1 Infection in 123 participants. Completed in 9 March 2022.
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 123 |
| Start date | 27 November 2017 |
| Primary completion | 8 March 2021 |
| Estimated completion | 9 March 2022 |
| Sites | 26 locations across Chile, France, United Kingdom, United States |
Merck Sharp & Dohme LLC — full company profile →
18 and older, any sex, with HIV-1 Infection. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Blood samples were collected and plasma human immunodeficiency virus 1 (HIV-1) ribonucleic acid (RNA) were quantified using a real time polymerase chain reaction (PCR) assay with a lower limit of detection of 40 copies/mL. Missing values were counted as failure.
| Group | Value | 95% CI |
|---|---|---|
| Islatravir 0.25 mg | 93.1 | |
| Islatravir 0.75 mg | 100.0 | |
| Islatravir 2.25 mg | 90.3 | |
| DOR/3TC/TDF | 90.3 |
Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL. Missing values were counted as failure.
| Group | Value | 95% CI |
|---|---|---|
| Islatravir 0.25 mg | 89.7 | |
| Islatravir 0.75 mg | 90.0 | |
| Islatravir 2.25 mg | 77.4 | |
| DOR/3TC/TDF | 83.9 |
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.
| Group | Value | 95% CI |
|---|---|---|
| Islatravir 0.25 mg | 26 | |
| Islatravir 0.75 mg | 27 | |
| Islatravir 2.25 mg | 24 | |
| DOR/3TC/TDF | 27 |
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.
| Group | Value | 95% CI |
|---|---|---|
| Islatravir 0.25 mg | 1 | |
| Islatravir 0.75 mg | 0 | |
| Islatravir 2.25 mg | 2 | |
| DOR/3TC/TDF | 1 |
Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL, and missing values were counted as failure. 3TC and placebo are discontinued from the regimen from Week 24 up to Week 52.
| Group | Value | 95% CI |
|---|---|---|
| Islatravir 0.25 mg | 86.2 | |
| Islatravir 0.75 mg | 90.0 | |
| Islatravir 2.25 mg | 88.9 | |
| DOR/3TC/TDF | 96.4 |
Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL, and missing values were counted as failure. 3TC and placebo are discontinued from the regimen from Week 24 up to Week 52.
| Group | Value | 95% CI |
|---|---|---|
| Islatravir 0.25 mg | 62.1 | |
| Islatravir 0.75 mg | 56.7 | |
| Islatravir 2.25 mg | 59.3 | |
| DOR/3TC/TDF | 60.7 |
Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL. Missing values were counted as failure. The percentage of participants with HIV-1 RNA \<50 copies in Part 4 are reported.
| Group | Value | 95% CI |
|---|---|---|
| DOR/ISL Continued (Part 4) | 85.1 | |
| DOR/ISL Switch (Part 4) | 95.5 |
Blood samples were collected and cluster of differentiation (CD4)+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication.
| Group | Value | 95% CI |
|---|---|---|
| Islatravir 0.25 mg | 220.5 | 170.3 – 270.8 |
| Islatravir 0.75 mg | 192.8 | 117.9 – 267.7 |
| Islatravir 2.25 mg | 142.9 | 89.9 – 196.0 |
| DOR/3TC/TDF | 142.1 | 105.7 – 178.5 |
Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication.
| Group | Value | 95% CI |
|---|---|---|
| Islatravir 0.25 mg | 182.0 | 119.6 – 244.5 |
| Islatravir 0.75 mg | 183.0 | 124.7 – 241.2 |
| Islatravir 2.25 mg | 100.7 | 25.0 – 176.3 |
| DOR/3TC/TDF | 181.4 | 137.2 – 225.6 |
Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication.
| Group | Value | 95% CI |
|---|---|---|
| Islatravir 0.25 mg | 243.4 | 165.5 – 321.3 |
| Islatravir 0.75 mg | 161.3 | 90.2 – 232.4 |
| Islatravir 2.25 mg | 136.5 | 57.0 – 216.0 |
| DOR/3TC/TDF | 268.9 | 188.5 – 349.3 |
Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication.
| Group | Value | 95% CI |
|---|---|---|
| Islatravir 0.25 mg | 204.4 | 102.0 – 306.7 |
| Islatravir 0.75 mg | 209.0 | 111.5 – 306.6 |
| Islatravir 2.25 mg | 162.9 | 70.2 – 255.5 |
| DOR/3TC/TDF | 270.0 | 183.2 – 356.8 |
Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Week 144 value. The change from baseline in CD4+ T-cell count at Week 192 (Part 4) are reported.
| Group | Value | 95% CI |
|---|---|---|
| DOR/ISL Continued (Part 4) | 3.8 | -1.9 – 9.5 |
| DOR/ISL Switch (Part 4) | -3.4 | -12.0 – 5.2 |
Time frame: For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Islatravir 0.25mg | Islatravir 0.75mg | Islatravir 2.25mg | DOR/3TC/TDF | DOR/ISL Continued | DOR/ISL Switch |
|---|---|---|---|---|---|---|---|
| Suicide attempt | Psychiatric disorders | — | — | — | — | — | — |
| Lymphadenopathy | Blood and lymphatic system disorders | — | — | — | — | — | — |
| Atrial fibrillation | Cardiac disorders | — | — | — | — | — | — |
| Long QT syndrome congenital | Congenital, familial and genetic disorders | — | — | — | — | — | — |
| Death | General disorders | — | — | — | — | — | — |
| Appendicitis | Infections and infestations | — | — | — | — | — | — |
| COVID-19 | Infections and infestations | — | — | — | — | — | — |
| Dysentery | Infections and infestations | — | — | — | — | — | — |
| Epididymitis | Infections and infestations | — | — | — | — | — | — |
| Large intestine infection | Infections and infestations | — | — | — | — | — | — |
| Pneumonia chlamydial | Infections and infestations | — | — | — | — | — | — |
| Pulmonary tuberculosis | Infections and infestations | — | — | — | — | — | — |
| Ankle fracture | Injury, poisoning and procedural complications | — | — | — | — | — | — |
| Burkitt's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — | — | — |
| Facial paralysis | Nervous system disorders | — | — | — | — | — | — |
| Alcohol withdrawal syndrome | Psychiatric disorders | — | — | — | — | — | — |
| Psychotic disorder | Psychiatric disorders | — | — | — | — | — | — |
| Suicidal ideation | Psychiatric disorders | — | — | — | — | — | — |
| Reaction | System | Islatravir 0.25mg | Islatravir 0.75mg | Islatravir 2.25mg | DOR/3TC/TDF | DOR/ISL Continued | DOR/ISL Switch |
|---|---|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | — | — | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — | — | — |
| Syphilis | Infections and infestations | — | — | — | — | — | — |
| Bronchitis | Infections and infestations | — | — | — | — | — | — |
| Vitamin D deficiency | Metabolism and nutrition disorders | — | — | — | — | — | — |
| Anxiety | Psychiatric disorders | — | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — | — |
| COVID-19 | Infections and infestations | — | — | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — | — | — |
| Fatigue | General disorders | — | — | — | — | — | — |
| Gastroenteritis | Infections and infestations | — | — | — | — | — | — |
| Pharyngitis | Infections and infestations | — | — | — | — | — | — |
| Sinusitis | Infections and infestations | — | — | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — | — |
| Influenza | Infections and infestations | — | — | — | — | — | — |
| Tonsillitis | Infections and infestations | — | — | — | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — | — | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — | — | — |
| Depression | Psychiatric disorders | — | — | — | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — | — | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — | — | — | — | — |
| Lymphadenopathy | Blood and lymphatic system disorders | — | — | — | — | — | — |
| Vertigo | Ear and labyrinth disorders | — | — | — | — | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — | — | — | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — | — | — | — | — |
| Aphthous ulcer | Gastrointestinal disorders | — | — | — | — | — | — |
| Proctitis | Gastrointestinal disorders | — | — | — | — | — | — |
| Asthenia | General disorders | — | — | — | — | — | — |
| Influenza like illness | General disorders | — | — | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — | — | — |
| Seasonal allergy | Immune system disorders | — | — | — | — | — | — |
| Anal chlamydia infection | Infections and infestations | — | — | — | — | — | — |
| Cellulitis | Infections and infestations | — | — | — | — | — | — |
| Conjunctivitis | Infections and infestations | — | — | — | — | — | — |
| Escherichia urinary tract infection | Infections and infestations | — | — | — | — | — | — |
Most-reported serious reactions: Suicide attempt, Lymphadenopathy, Atrial fibrillation, Long QT syndrome congenital, Death, Appendicitis, COVID-19, Dysentery.
Data from ClinicalTrials.gov NCT03272347 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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