Randomized, double blind, safety, efficacy Doravirine/Islatravir in Tx naive

JRCT ID: jRCT2031210024

Registered date:09/04/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: HIV-1 Infection
• Date of first enrollment: 07/05/2021
• Target sample size: 680
• Countries of recruitment: United States of America,Japan,Argentina,Japan,Canada,Japan,Chile,Japan,Colombia,Japan,France,Japan,Germany,Japan,Israel,Japan,Italy,Japan,South Africa,Japan,Spain,Japan,Taiwan,Japan
• Study type: Interventional

Intervention(s)

Doravirine/Islatravir(100 mg/0.75 mg) FDC tablet taken once daily by mouth and Bictegravir/Emtricitabine/Tenofovir alafenamide placebo taken by mouth for 96 weeks
or
Bictegravir/Emtricitabine/Tenofovir alafenamide(50 mg/200 mg/25 mg) FDC tablet taken once daily by mouth and Doravirine/Islatravir placebo taken by mouth for 96 weeks

Outcome(s)

Primary Outcome

- Percentage of participants with HIV-1 RNA <50 copies/mL* [Time Frame: Week 48]
- Percentage of participants experiencing >=1 adverse events (AEs)** [Time Frame: Up to 98 weeks]
- Percentage of participants discontinuing from study treatment due to AE(s)** [Time Frame: Up to 96 weeks]

* The percentage of participants with HIV-1 RNA <50 copies/mL will be determined at the central laboratory with an Abbott Real Time Polymerase Chain Reaction (PCR) assay with a lower limit of detection (LLOD) of 40 copies/mL.
** 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 interventions.

Secondary Outcome

-Percentage of participants with HIV-1 RNA <50 copies/mL [Time Frame: Week 96]
-Percentage of participants with HIV-1 RNA <40 copies/mL [Time Frame: Week 48]
-Percentage of participants with HIV-1 RNA <200 copies/mL [Time Frame: Week 48]
-Percentage of participants with HIV-1 RNA <40 copies/mL [Time Frame: Week 96]
-Percentage of participants with HIV-1 RNA <200 copies/mL [Time Frame: Week 96]
-Change from baseline in cluster of differentiation 4+ (CD4+) T-cell counts [Time Frame: Day 1 (baseline) and Week 48]
-Change from baseline in CD4+ T-cell counts [Time Frame: Day 1 (baseline) and Week 96]
- Incidence of viral resistance-associated substitutions (RASs) [Time Frame: Week 48]
- Incidence of viral RASs [Time Frame: Week 96]
- Change from baseline in body weight [Time Frame: Day 1 (baseline) and Week 48]
-Change from baseline in body weight [Time Frame: Day 1 (baseline) and Week 96]

* The percentage of participants with HIV-1 RNA <50 copies/mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
**CD4+ T-cell counts will be measured by a central laboratory.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Is HIV-1 positive
-Is naive to antiretroviral therapy (ART) defined as having received <=10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection including prevention of mother-to-child transmission up to 1 month prior to screening.
-A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: 1) Is not a woman of childbearing potential (WOCBP); 2) Is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis)*, **

* A WOCBP must have a negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) within 24 hours before the first dose of study intervention
** If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required

Exclude 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 an active diagnosis of hepatitis due to any cause, including active HBV infection (defined as hepatitis B surface antigen [HBsAg]-positive or hepatitis B virus deoxyribonucleic acid [HBV DNA]-positive)
-Has a history of malignancy <=5 years prior to signing 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
-Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1
-Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapy from 45 days prior to Day 1 through the study intervention period
-Is currently participating in or has participated in a clinical study with an investigational compound or device from 45 days prior to Day 1 through the study intervention period
-Has a documented or known virologic resistance to specific approved HIV-1 reverse transcriptase inhibitor, or any study intervention
-Has exclusionary laboratory values within 45 days prior to Day 1
-Is female and is expecting to conceive or donate eggs at any time during the study

Related Information

• Primary Sponsor: Tanaka Yoshiyuki
• Secondary ID(s): NCT04233879