HIV Infection
Conditions
Brief summary
The purpose of this study is to evaluate the safety and tolerability of DOR/ISL in adult participants with HIV-1 who had been previously treated with DOR/ISL in earlier clinical studies. There are no formal hypotheses to be tested in this study.
Interventions
DRUGDOR/ISL
FDC tablet of 100 mg doravirine (DOR)/0.25 mg islatravir (ISL) taken once daily
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is currently receiving doravirine/islatravir (DOR/ISL) adult fixed dose combination (FDC) tablet in Merck Sharp & Dohme (MSD)-sponsored clinical studies (MK-8591A-018, -020, and -033 \[except for heavily treatment-experienced (HTE) participants\]).
Exclusion criteria
* Has confirmed HIV-1 RNA ≥200 copies/mL in MSD DOR/ISL (100 mg/0.75 mg) MK-8591A-018 /-020, or at screening for participants entering from DOR/ISL (100 mg/0.75 mg) MK-8591A-033. * Has confirmatory laboratory findings for cluster of differentiation 4+ (CD4+) T-cell counts or lymphocyte counts in the prior DOR/ISL study that meet criteria for discontinuation of DOR/ISL. * Is a HTE participant receiving treatment in MK-8591A-019 or -033.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with One or More Adverse Event (AE) | Up to 96 Weeks | 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. 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 intervention. The percentage of participants who experience an AE through Week 96 will be presented. |
| Percentage of participants who Discontinue Study Intervention Due to an AE | Up to 96 Weeks | 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. 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 intervention. The percentage of participants who discontinue study intervention due to an AE through Week 96 will be presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with HIV-1 Ribonucleic Acid (RNA) ≥50 copies/mL at Week 96 | Week 96 | The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96 will be reported. |
| Percentage of Participants with HIV-1 RNA <50 copies/mL at Week 96 | Week 96 | The 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 96 | Week 96 | The percentage of participants with HIV-1 RNA \<200 copies/mL at Week 96 will be reported |
| Percentage of Participants with Evidence of Viral Drug Resistance-Associated Substitutions | Up to Week 96 | Viral drug resistance is defined as participants with HIV-1 RNA ≥400 copies/mL and/or genotypic or phenotypic data showing evidence of resistance to the study intervention. The percentage of participants who demonstrate drug resistance through Week 96 will be presented. |
Countries
Argentina, Australia, Canada, Chile, Colombia, Israel, Japan, New Zealand, Puerto Rico, Russia, South Africa, Switzerland, Taiwan, United Kingdom, United States
Outcome results
None listed