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NCT Number: NCT05705349

DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)

This is a randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL [MK-8591A]) in treatment-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that DOR/ISL is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

HIV-1 Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fundación Huésped ( Site 5850), CABA, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Is HIV-1 positive with plasma HIV-1 RNA ≥500 copies/mL at screening
  • Is naïve to antiretroviral therapy (ART) defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection
  • If female, is not a participant of childbearing potential (POCBP); or if a POCBP, is 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 hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
  • Has a diagnosis of an active AIDS-defining opportunistic infection within 30 days prior to screening
  • Has active hepatitis B infection (defined as hepatitis B surface antigen [HBsAg]-positive or HBV deoxyribonucleic acid [DNA]-positive).
  • Has chronic hepatitis C virus (HCV) infection (detectable HCV ribonucleic acid [RNA]) and lab values are 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
  • Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality, or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate

Treatment and study plan

DOR/ISL

Drug

Fixed dose combination tablet containing DOR/ISL 100 mg/0.25 mg taken by mouth.

Other names: MK-8591A

BIC/FTC/TAF

Drug

Fixed dose combination tablet containing BIC/FTC/TAF 50 mg/200 mg/25 mg taken by mouth.

Placebo to DOR/ISL

Drug

Placebo tablet matched to DOR/ISL tablet taken by mouth.

Placebo to BIC/FTC/TAF

Drug

Placebo tablet matched to BIC/FTC/TAF tablet taken by mouth.

Primary outcomes

  1. Percentage of participants with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) <50 copies/mL at Week 48

    Time frame: Week 48

    Plasma HIV-1 RNA quantification will be performed at the central laboratory using a polymerase chain reaction (PCR) assay with a lower limit of detection of <50 copies/mL.

  2. Percentage of participants experiencing ≥1 adverse event (AE) through Week 48

    Time frame: Up to 48 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.

  3. Percentage of participants discontinuing from study treatment due to an AE through Week 48

    Time frame: Up to 48 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.

Secondary outcomes

  1. Percentage of participants with HIV-1 RNA <50 copies/mL at Week 96

    Time frame: Week 96

    Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of <50 copies/mL.

  2. Percentage of participants with HIV-1 RNA <50 copies/mL at Week 144

    Time frame: Week 144

    Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of <50 copies/mL.

  3. Percentage of participants with HIV-1 RNA <200 copies/mL at Week 48

    Time frame: Week 48

    Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of <50 copies/mL.

  4. Percentage of participants with HIV-1 RNA <200 copies/mL at Week 96

    Time frame: Week 96

    Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of <50 copies/mL.

  5. Percentage of participants with HIV-1 RNA <200 copies/mL at Week 144

    Time frame: Week 144

    Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of <50 copies/mL.

  6. Change from baseline in cluster of differentiation 4+ (CD4+) T-cells at Week 48

    Time frame: Baseline (Day 1) and Week 48

    CD4+ T-cells are quantified with a T and B lymphocyte and natural killer cell (TBNK) panel.

  7. Change from baseline in CD4+ T-cells at Week 96

    Time frame: Baseline (Day 1) and Week 96

    CD4+ T-cells are quantified with a TBNK panel.

  8. Change from baseline in CD4+ T-cells at Week 144

    Time frame: Baseline (Day 1) and Week 144

    CD4+ T-cells are quantified with a TBNK panel.

  9. Incidence of viral drug resistance

    Time frame: Up to 96 weeks

    Plasma samples will be collected for genotypic and phenotypic HIV-1 viral drug resistance testing and used to assess resistance-associated substitutions and viral susceptibility as applicable during the study.

  10. Change from baseline in body weight at Week 48

    Time frame: Baseline (Day 1) and Week 48

    Body weight will be collected throughout the study.

  11. Change from baseline in body weight at Week 96

    Time frame: Baseline (Day 1) and Week 96

    Body weight will be collected throughout the study.

  12. Change from baseline in body weight at Week 144

    Time frame: Baseline (Day 1) and Week 144

    Body weight will be collected throughout the study.

  13. Percentage of participants experiencing ≥1 AE through Week 144

    Time frame: Up to 144 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.

  14. Percentage of participants discontinuing from study treatment due to an AE through Week 144

    Time frame: Up to 144 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in HIV-1 Infected Treatment-Naïve Participants

Important dates

Study start
2023
Primary completion
2025
Study completion
2029
First posted
Jan 30, 2023
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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