HIV-1 InfectionPhase 2NCT04295772
Doravirine/Islatravir (DOR/ISL) in Pediatric Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are <18 Years of Age and Weigh ≥35 kg (MK-8591A-028)
A Phase 2 study testing DOR/ISL in people with HIV-1 Infection, run by Merck Sharp & Dohme LLC at 17 sites in 5 countries.
Trial summary
This is a phase 2, single-group, multi-site, open-label study of an islatravir/doravirine (ISL/DOR, MK-8591A) fixed dose combination (FDC) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in pediatric participants who are virologically suppressed (VS) on antiretroviral therapy (ART) for ≥3… Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- DOR/ISL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 17 sitesin 5 countries
- Study dates
- 26 Nov 2020to 25 Jan 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Is HIV-1 positive, is <18 years of age, and weighs ≥35 kg at screening.
- VS Participants: Is HIV-1 positive at Screening with plasma HIV-1 RNA <50 copies/mL and has been receiving continuous, stable oral 2-drug or 3-drug combination ART ± PK booster with documented viral suppression for ≥3 months prior to providing documented informed consent/assent and has no history of prior virologic treatment failure on any past or current regimen.
- TN Participants: Is HIV-1 positive at Screening with plasma HIV-1 RNA ≥500 copies/mL and is naive to ART defined as having received <=10 days of prior therapy with any antiretrovirals following HIV-1 diagnosis other than pre-exposure prophylaxis (PrEP) or potentially exposed person (PEP).
- If female, is not pregnant or breastfeeding, and is either 1) not a woman of childbearing potential (WOCBP) or 2) is a WOCBP and is using acceptable contraception or is abstinent.
Who cannot join
- Has HIV-2 infection.
- Has hypersensitivity or other contraindication to any of the components of the study drugs as determined by the investigator.
- Has an active diagnosis of hepatitis due to any cause, including active hepatitis B virus (HBV) infection (defined as hepatitis B surface antigen [HBsAg]-positive or HBV deoxyribonucleic acid [DNA] positive).
- 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.
- Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies from 45 days prior to Day 1 through the study treatment period.
Show all 11Show fewer
- Is currently taking long-acting cabotegravir-rilpivirine.
- Is currently participating in or has participated in an interventional clinical study with an investigational compound or device from 45 days prior to Day 1 through the study treatment period.
- Has a documented or known virologic resistance to DOR/ISL (DOR resistance substitutions in reverse transcriptase: V106A/M, V108I, Y188L, H221Y, P225H, F227C/L, M230I/L, L234I, P236L, or Y318F; ISL resistance substitution in reverse transcriptase: M184V/I).
- Has exclusionary laboratory values.
- Is female and expecting to conceive or donate eggs at any time during the study.
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
United States4 sites
Emory Children's Center ( Site 1805)
Atlanta, Georgia, 30322
Johns Hopkins University ( Site 1800)
Baltimore, Maryland, 21287
Duke University ( Site 1807)
Durham, North Carolina, 27705
Children's National Medical Center ( Site 1816)
Washington D.C., District of Columbia, 20010
Russia4 sites
Krasnoyarsk Regional Center for Prevention and Control of AIDS ( Site 1507)
Krasnoyarsk, Krasnoyarsk Krai, 660049
Infectious Clinical Hospital #2 ( Site 1501)
Moscow, Moscow, 105275
FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 1500)
Saint Petersburg, Sankt-Peterburg, 196645
Saratov Regional Clinical Center for Prophylaxis and Control of AIDS ( Site 1505)
Saratov, Saratov Oblast, 410009
South Africa4 sites
King Edward Hospital ( Site 1900)
Durban, KwaZulu-Natal, 4001
Perinatal HIV Research Unit ( Site 1902)
Johannesburg, Gauteng, 1864
Wits Reproductive Health and HIV Institute (WRHI) ( Site 1903)
Johannesburg, Gauteng, 2000
Empilweni Services and Research Unit ( Site 1904)
Johannesburg, Gauteng, 2093
Thailand3 sites
Chulalongkorn University ( Site 1602)
Bangkok, Bangkok, 10330
Siriraj Hospital ( Site 1601)
Bangkok, Bangkok, 10700
Research Institute for Health Sciences ( Site 1603)
Chiang Mai, 50200
Italy2 sites
Azienda Ospedaliera Luigi Sacco ( Site 1300)
Milan, 20157
IRCCS Ospedale Pediatrico Bambino Gesu ( Site 1301)
Roma, 00165
About this study
Official title: A Phase 2 Clinical Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Doravirine/Islatravir in Pediatric Participants With HIV-1 Infection Who Are Virologically Suppressed or Treatment-Naïve, Are Less Than 18 Years of Age, and Weigh Greater Than or Equal to 35 kg
This is a phase 2, single-group, multi-site, open-label study of an islatravir/doravirine (ISL/DOR, MK-8591A) fixed dose combination (FDC) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in pediatric participants who are virologically suppressed (VS) on antiretroviral therapy (ART) for ≥3 months or are treatment-naive (TN). The primary purposes of the study are 1) to examine the steady-state pharmacokinetics (PK) of ISL in plasma; 2) the steady-state PK of ISL-triphosphate (ISL-TP) in peripheral blood mononuclear cells (PBMCs); and 3) to examine the safety and tolerability of ISL/DOR.
Read the detailed description
As of protocol amendment 03 (approved 08-Feb-2022), all participants have been discontinued from study therapy and will be switched to non-study antiretroviral therapy and monitored for safety. The present results cover data obtained through the cut-off date of 30-Mar-2022, and will be updated once monitoring is completed.
- Conditions
- HIV-1 Infection
- Being tested
- DOR/ISL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOR/ISLDrug
Also called MK-8591A, Doravirine/islatravir
100 mg DOR/0.75 mg ISL FDC tablet taken once daily by mouth.
| Study group | Role | What they receive |
|---|---|---|
| DOR/ISL | Experimental | Pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks. Receives: Drug: DOR/ISL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Drug Concentration-time Curve From 0 to 24 Hours Post-dose (AUC0-24) of Islatravir (ISL)
The AUC0-24 of ISL in plasma was determined at steady state.
Measured: Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28
Maximum Plasma Concentration (Cmax) of ISL
The Cmax of ISL in plasma was determined at steady state.
Measured: Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28
Time to Reach Maximum Plasma Concentration (Tmax) of ISL
The Tmax of ISL in plasma was determined at steady state.
Measured: Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28
Apparent Plasma Terminal Half-life (t½) of ISL
The t½ of ISL in plasma was determined at steady state.
Measured: Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28
Apparent Total Clearance From Plasma (CL/F) of ISL
The CL/F of ISL from plasma was determined at steady state.
Measured: Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28
Apparent Volume of Distribution During Terminal Phase (Vz/F) of ISL
The Vz/F of ISL was determined at steady state.
Measured: Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28
AUC0-last of ISL-triphosphate (ISL-TP) in Peripheral Blood Mononuclear Cells (PBMCs)
The AUC0-24 of ISL-TP in PBMCs was determined at steady state.
Measured: Pre-dose, and 4 and 24 hours post-dose on Day 28
Cmax of ISL-TP in PBMCs
The Cmax of ISL-TP in PBMCs was determined at steady state.
Measured: Pre-dose, and 4, and 24 hours post-dose on Day 28
C24 of ISL-TP in PBMCs
The C24 of ISL-TP in PBMCs was determined at steady state.
Measured: 24 hours post-dose on Day 28
Number of Participants Experiencing ≥1 Adverse Event (AE)
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.
Measured: Up to 24 weeks
Number of Participants Discontinuing From Study Treatment Due to an AE
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.
Measured: Up to 24 weeks
Secondary outcomes (9)
Percentage of Virologically Suppressed (VS) Participants With HIV-1 Ribonucleic Acid (RNA) ≥50 Copies/mL
The percentage of VS participants with HIV-1 RNA ≥50 copies/mL was 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.
Measured: Week 24
Percentage of VS Participants With HIV-1 RNA <50 Copies/mL
The percentage of VS participants with HIV-1 RNA <50 copies/mL will be determined at the central laboratory with an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Measured: Week 24
Percentage of Treatment Naive (TN) Participants With HIV-1 RNA <50 Copies/mL
The percentage of TN participants with HIV-1 RNA <50 copies/mL will be determined at the central laboratory with an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Measured: Week 24
Change From Baseline in Cluster of Differentiation 4+ (CD4+) T-cells in VS Participants
CD4+ T-cell counts were measured by a central laboratory. Negative and positive results represent a decrease and increase, respectively, from baseline CD4+ T-cell counts.
Measured: Baseline (Day 1) and Week 24
Change From Baseline in CD4+ T-cells in TN Participants
CD4+ T-cell counts were measured by a central laboratory. Negative and positive results represent a decrease and increase, respectively, from baseline CD4+ T-cell counts.
Measured: Baseline (Day 1) and Week 24
Incidence of Viral Drug Resistance to DOR
The number of participants with viral drug resistance to DOR was determined.
Measured: Up to 24 weeks
Incidence of Viral Drug Resistance to ISL
The number of participants with viral drug resistance to ISL was determined.
Measured: Up to 24 weeks
Palatability of DOR/ISL Tablet
The palatability of the DOR/ISL tablet (whole or split) was assessed with a modified 5-point facial hedonic scale. Responses ranged from 1 ("very bad") to 5 ("very good"). Data show the number of VS and TN participants responding at each score at the designated time points.
Measured: Baseline (Day 1), Week 4, and Week 24
Acceptability of DOR/ISL Tablet
The acceptability of the DOR/ISL tablet (whole or split) was assessed. Acceptability was assessed by monitoring for refusing the tablet, throwing up or spitting out the tablet, and gagging on the tablet. Data show the number of VS and TN participants responding at each score at the designated time points.
Measured: Baseline (Day 1), Week 4, and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start26 Nov 2020
- Primary completion21 Dec 2021
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295772
- Sponsor's protocol ID
- 8591A-028
- Other IDs
- MK-8591A-028, 2019-003597-10, 2019
- Status last verified
- Jan 2024
- First submitted
- 3 Mar 2020
- Last updated
- 31 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Clinical Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Doravirine/Islatravir in Pediatric Participants With HIV-1 Infection Who Are Virologically Suppressed or Treatment-Naïve, Are Less Than 18 Years of Age, and Weigh Greater Than or Equal to 35 kg
- ClinicalTrials.gov ID
- NCT04295772
- Acronym / sponsor ID
- 8591A-028
- Conditions
- HIV-1 Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 4 Mar 2020 (actual)
- Results
- Posted 24 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2, single-group, multi-site, open-label study of an islatravir/doravirine (ISL/DOR, MK-8591A) fixed dose combination (FDC) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in pediatric participants who are virologically suppressed (VS) on antiretroviral therapy (ART) for ≥3 months or are treatment-naive (TN). The primary purposes of the study are 1) to examine the steady-state pharmacokinetics (PK) of ISL in plasma; 2) the steady-state PK of ISL-triphosphate (ISL-TP) in peripheral blood mononuclear cells (PBMCs); and 3) to examine the safety and tolerability of ISL/DOR.
Detailed description
As of protocol amendment 03 (approved 08-Feb-2022), all participants have been discontinued from study therapy and will be switched to non-study antiretroviral therapy and monitored for safety. The present results cover data obtained through the cut-off date of 30-Mar-2022, and will be updated once monitoring is completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DOR/ISL | Experimental | Drug: DOR/ISLPediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Is HIV-1 positive, is <18 years of age, and weighs ≥35 kg at screening.
- VS Participants: Is HIV-1 positive at Screening with plasma HIV-1 RNA <50 copies/mL and has been receiving continuous, stable oral 2-drug or 3-drug combination ART ± PK booster with documented viral suppression for ≥3 months prior to providing documented informed consent/assent and has no history of prior virologic treatment failure on any past or current regimen.
- TN Participants: Is HIV-1 positive at Screening with plasma HIV-1 RNA ≥500 copies/mL and is naive to ART defined as having received <=10 days of prior therapy with any antiretrovirals following HIV-1 diagnosis other than pre-exposure prophylaxis (PrEP) or potentially exposed person (PEP).
- If female, is not pregnant or breastfeeding, and is either 1) not a woman of childbearing potential (WOCBP) or 2) is a WOCBP and is using acceptable contraception or is abstinent.
Key exclusion criteria (11 listed)
- Has HIV-2 infection.
- Has hypersensitivity or other contraindication to any of the components of the study drugs as determined by the investigator.
- Has an active diagnosis of hepatitis due to any cause, including active hepatitis B virus (HBV) infection (defined as hepatitis B surface antigen [HBsAg]-positive or HBV deoxyribonucleic acid [DNA] positive).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DOR/ISLAlso: MK-8591A, Doravirine/islatravir100 mg DOR/0.75 mg ISL FDC tablet taken once daily by mouth. | Drug | DOR/ISL |
Primary outcome
Area Under the Plasma Drug Concentration-time Curve From 0 to 24 Hours Post-dose (AUC0-24) of Islatravir (ISL)
Time frame: Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28
The AUC0-24 of ISL in plasma was determined at steady state.
Maximum Plasma Concentration (Cmax) of ISL
Time frame: Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28
The Cmax of ISL in plasma was determined at steady state.
Time to Reach Maximum Plasma Concentration (Tmax) of ISL
Time frame: Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28
The Tmax of ISL in plasma was determined at steady state.
Apparent Plasma Terminal Half-life (t½) of ISL
Time frame: Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28
The t½ of ISL in plasma was determined at steady state.
Apparent Total Clearance From Plasma (CL/F) of ISL
Time frame: Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28
The CL/F of ISL from plasma was determined at steady state.
Apparent Volume of Distribution During Terminal Phase (Vz/F) of ISL
Time frame: Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28
The Vz/F of ISL was determined at steady state.
AUC0-last of ISL-triphosphate (ISL-TP) in Peripheral Blood Mononuclear Cells (PBMCs)
Time frame: Pre-dose, and 4 and 24 hours post-dose on Day 28
The AUC0-24 of ISL-TP in PBMCs was determined at steady state.
Cmax of ISL-TP in PBMCs
Time frame: Pre-dose, and 4, and 24 hours post-dose on Day 28
The Cmax of ISL-TP in PBMCs was determined at steady state.
C24 of ISL-TP in PBMCs
Time frame: 24 hours post-dose on Day 28
The C24 of ISL-TP in PBMCs was determined at steady state.
Number of Participants Experiencing ≥1 Adverse Event (AE)
Time frame: Up to 24 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.
Number of Participants Discontinuing From Study Treatment Due to an AE
Time frame: Up to 24 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.
9 secondary outcomes
Percentage of Virologically Suppressed (VS) Participants With HIV-1 Ribonucleic Acid (RNA) ≥50 Copies/mL
Time frame: Week 24
Percentage of VS Participants With HIV-1 RNA <50 Copies/mL
Time frame: Week 24
Percentage of Treatment Naive (TN) Participants With HIV-1 RNA <50 Copies/mL
Time frame: Week 24
Change From Baseline in Cluster of Differentiation 4+ (CD4+) T-cells in VS Participants
Time frame: Baseline (Day 1) and Week 24
Change From Baseline in CD4+ T-cells in TN Participants
Time frame: Baseline (Day 1) and Week 24
Incidence of Viral Drug Resistance to DOR
Time frame: Up to 24 weeks
Incidence of Viral Drug Resistance to ISL
Time frame: Up to 24 weeks
Palatability of DOR/ISL Tablet
Time frame: Baseline (Day 1), Week 4, and Week 24
Acceptability of DOR/ISL Tablet
Time frame: Baseline (Day 1), Week 4, and Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Related trials for HIV-1 Infection
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
Not yet recruitingPhase 4
NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
HIV Infections, Opioid Use Disorder
Enrolling by invitation
Effect of Omega-3 Supplementation on Pregnant Outcomes and Inflammation Markers of Women Infected With HIV Using Antiretroviral Therapy
Pregnant HIV Positive Women
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
HC-HMP: Healthy Choices Implementation Trial
Alcohol Drinking, HIV Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DOR/ISL in people with HIV-1 Infection, run by Merck Sharp & Dohme LLC at 17 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Russia, South Africa, Thailand, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Plasma Drug Concentration-time Curve From 0 to 24 Hours Post-dose (AUC0-24) of Islatravir (ISL) (time frame: Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.