HIV-1Phase 1NCT02217904

A Study of Islatravir (MK-8591) in Anti-Retroviral Therapy-Naive, Human Immunodeficiency Virus-1 Infected Participants (MK-8591-003)

A Phase 1 study testing 1 mg islatravir, 2 mg islatravir and 10 mg islatravir in people with HIV-1, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: HIV-1
What is being tested?: 1 mg islatravir, 2 mg islatravir and 10 mg islatravir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: No sites listed yet
Study dates: 17 Sep 2015to 11 May 2017
Phase: Phase 1
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 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Non-pregnant, non-breast feeding, postmenopausal or surgically sterile female
Female with reproductive potential agrees to use (or have male partner use) two acceptable methods of birth control
Male agrees to use acceptable method of contraception during study and for 90 days after last dose of trial drug
Has stable baseline health, other than HIV infection
Has no significantly abnormal electrocardiogram
Is HIV-1 positive

Show all 12Show fewer

Have a screening plasma HIV-1 RNA ≥ 10,000 copies/mL within 30 days prior to the treatment phase of this study. For inclusion in Panel Islatravir Extended Observation, participants must also have a screening plasma HIV-1 RNA ≤ 25,000 copies/mL within 30 days prior to the treatment phase.
Is ART naive
Has not received any investigational agent or marketed ART within 30 days of trial drug administration
Is diagnosed with HIV-1 infection >= 3 months prior to screening
Is willing to receive no other ART during treatment phase of study
Has no evidence of mutations conferring resistance to nucleoside reverse transcriptase inhibitors (NRTIs)

Who cannot join

Is mentally or legally institutionalized/incapacitated, or has significant emotional problems, or has a history of clinically significant psychiatric disorder of the last 5 years
Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological (outside of HIV-1 infection), renal, respiratory, genitourinary, major neurological abnormalities or diseases
Has a history of cancer (malignancy)
Has a history of significant multiple and/or severe allergies, or had an anaphylactic reaction to drugs or food
Is positive for hepatitis B surface antigen
Has a history of chronic Hepatitis C

Show all 11Show fewer

Had major surgery or lost 500 mL of blood with 4 weeks prior to screening visit
Has participated in another investigational trial within 4 weeks prior to dosing visit
Will use any medications, prescribed drugs, or herbal remedies 4 weeks prior to dosing of trial drug, up to the post-trial visit
Consumes excessive amounts of alcohol, caffeinated beverages, or tobacco products
Uses illicit drugs or has a history of drug abuse within the prior 2 years

About this study

Official title: A Single-Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics, and Anti-Retroviral Activity of MK-8591 Monotherapy in Anti-Retroviral Therapy (ART)-Naive, HIV-1 Infected Patients

This study will evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral therapy (ART) activity of islatravir (MK-8591) monotherapy in ART-naive, human immunodeficiency virus-1 (HIV-1) infected participants. The primary hypothesis is that at a safe and tolerable dose of islatravir, the true mean difference in the plasma HIV-1 ribonucleic acid (RNA) reduction from baseline between islatravir and placebo is at least 0.5 log (base10) copies/mL.

Conditions: HIV-1
Being tested: 1 mg islatravir, 2 mg islatravir, 10 mg islatravir, 30 mg islatravir, 0.5 mg islatravir

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

1 mg islatravirDrug
Also called MK-8591
Single oral dose of 1 mg islatravir administered following ≥8 hour fast
2 mg islatravirDrug
Also called MK-8591
Single oral dose of 2 mg islatravir administered following ≥8 hour fast
10 mg islatravirDrug
Also called MK-8591
Single oral dose of 10 mg islatravir administered following ≥8 hour fast
30 mg islatravirDrug
Also called MK-8591
Single oral dose of 30 mg islatravir administered following ≥8 hour fast
0.5 mg islatravirDrug
Also called MK-8591
Single oral dose of 0.5 mg islatravir administered following ≥8 hour fast
0.25 mg islatravirDrug
Also called MK-8591
Single oral dose of 0.25 mg islatravir administered following ≥8 hour fast

Study groups in NCT02217904
Study group	Role	What they receive
Islatravir 1 mg	Experimental	Single oral dose of islatravir 1 mg Receives: Drug: 1 mg islatravir
Islatravir 2 mg	Experimental	Single oral dose of islatravir 2 mg Receives: Drug: 2 mg islatravir
Islatravir 10 mg	Experimental	Single oral dose of islatravir 10 mg Receives: Drug: 10 mg islatravir
Islatravir 30 mg	Experimental	Single oral dose of islatravir 30 mg Receives: Drug: 30 mg islatravir
Islatravir 0.5 mg	Experimental	Single oral dose of islatravir 0.5 mg Receives: Drug: 0.5 mg islatravir
Islatravir 0.25 mg	Experimental	Single oral dose of islatravir 0.25 mg Receives: Drug: 0.25 mg islatravir
Islatravir 30 mg Extended Observation	Experimental	Single oral dose of 30 mg islatravir administered following >8 hour fast. Participants will be closely monitored for viral load for up to approximately 21 days prior to starting standard of care ART. Receives: Drug: 30 mg islatravir

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Plasma HIV-1 RNA at 168 Hours Post-Dose
Plasma HIV-1 RNA was measured using the Roche COBAS Ampliprep/COBAS TaqMan HIV-1 test v.2.0, which has a linear range from 20 to 10,000,000 copies/mL. The lower limit of detection has 100% specificity at 20 copies/mL. Additionally, the test increases the probability of detection and expands coverage by targeting two highly conserved regions of the HIV-1 genome to compensate for the possibility of mutations or mismatches.
Measured: Baseline and 168 hours (7 days) post-dose
Number of Participants With One or More Adverse Events
An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Measured: Up to 21 days post-dose

Secondary outcomes (9)

Area Under the Concentration-Time Curve of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells From Time 0 to 168 Hours (AUC0-168hr)
Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine AUC0-168hr.
Measured: 4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.
Maximum Concentration (Cmax) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells
Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine Cmax.
Measured: 4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.
Concentration of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells at 168 Hours Post-Dose (C168hr)
Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine C168hr.
Measured: 168 hours after islatravir administration
Time to Maximum Concentration (Tmax) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells
Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine TMax.
Measured: 4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.
Apparent Terminal Half-Life (t1/2) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells
Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine apparent terminal t1/2.
Measured: 4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.
Area Under the Plasma Concentration-Time Curve of Islatravir From Time 0 to 168 Hours (AUC0-168hr)
Blood was collected for the determination of AUC0-168hr of islatravir in plasma.
Measured: Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration. Value at 168 hours was extrapolated.
Maximum Plasma Concentration (Cmax) of Islatravir
Blood was collected for the determination of Cmax of islatravir in plasma.
Measured: Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration
Time to Maximum Plasma Concentration (Tmax) of Islatravir
Blood was collected for the determination of Tmax of islatravir in plasma.
Measured: Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration
Apparent Terminal Half-Life (t1/2) of Islatravir in Plasma
Blood was collected for the determination of apparent terminal t1/2 of islatravir in plasma.
Measured: Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Sep 201511 May 2017

First posted15 Aug 2014 (estimated)
Study start17 Sep 2015
Primary completion11 May 2017
Study completion11 May 2017

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV-1Studies 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02217904
Sponsor's protocol ID: 8591-003
Other IDs: 2014-002192-28, MK-8591-003, 2014
Status last verified: Jul 2019
First submitted: 13 Aug 2014
Last updated: 12 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Schurmann D, Rudd DJ, Zhang S, De Lepeleire I, Robberechts M, Friedman E, Keicher C, Huser A, Hofmann J, Grobler JA, Stoch SA, Iwamoto M, Matthews RP. Safety, pharmacokinetics, and antiretroviral activity of islatravir (ISL, MK-8591), a novel nucleoside reverse transcriptase translocation inhibitor, following single-dose administration to treatment-naive adults infected with HIV-1: an open-label, phase 1b, consecutive-panel trial. Lancet HIV. 2020 Mar;7(3):e164-e172. doi: 10.1016/S2352-3018(19)30372-8. Epub 2020 Jan 3.
PubMed 31911147

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All HIV-1 trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics, and Anti-Retroviral Activity of MK-8591 Monotherapy in Anti-Retroviral Therapy (ART)-Naive, HIV-1 Infected Patients
ClinicalTrials.gov ID: NCT02217904
Acronym / sponsor ID: 8591-003
Conditions: HIV-1
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 17 Sep 2015 (actual)
Primary completion: 11 May 2017 (actual)
Study completion: 11 May 2017 (actual)
First posted: 15 Aug 2014 (estimated)
Results: Posted 3 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 7

Arm	Type	Receives
Islatravir 1 mg	Experimental	Drug: 1 mg islatravirSingle oral dose of islatravir 1 mg
Islatravir 2 mg	Experimental	Drug: 2 mg islatravirSingle oral dose of islatravir 2 mg
Islatravir 10 mg	Experimental	Drug: 10 mg islatravirSingle oral dose of islatravir 10 mg
Islatravir 30 mg	Experimental	Drug: 30 mg islatravirSingle oral dose of islatravir 30 mg
Islatravir 0.5 mg	Experimental	Drug: 0.5 mg islatravirSingle oral dose of islatravir 0.5 mg
Islatravir 0.25 mg	Experimental	Drug: 0.25 mg islatravirSingle oral dose of islatravir 0.25 mg
Islatravir 30 mg Extended Observation	Experimental	Drug: 30 mg islatravirSingle oral dose of 30 mg islatravir administered following >8 hour fast. Participants will be closely monitored for viral load for up to approximately 21 days prior to starting standard of care ART.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Non-pregnant, non-breast feeding, postmenopausal or surgically sterile female
Female with reproductive potential agrees to use (or have male partner use) two acceptable methods of birth control
Male agrees to use acceptable method of contraception during study and for 90 days after last dose of trial drug
Has stable baseline health, other than HIV infection
Has no significantly abnormal electrocardiogram

Key exclusion criteria (11 listed)

Is mentally or legally institutionalized/incapacitated, or has significant emotional problems, or has a history of clinically significant psychiatric disorder of the last 5 years
Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological (outside of HIV-1 infection), renal, respiratory, genitourinary, major neurological abnormalities or diseases
Has a history of cancer (malignancy)
Has a history of significant multiple and/or severe allergies, or had an anaphylactic reaction to drugs or food
Is positive for hepatitis B surface antigen

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
1 mg islatravirAlso: MK-8591Single oral dose of 1 mg islatravir administered following ≥8 hour fast	Drug	Islatravir 1 mg
2 mg islatravirAlso: MK-8591Single oral dose of 2 mg islatravir administered following ≥8 hour fast	Drug	Islatravir 2 mg
10 mg islatravirAlso: MK-8591Single oral dose of 10 mg islatravir administered following ≥8 hour fast	Drug	Islatravir 10 mg
30 mg islatravirAlso: MK-8591Single oral dose of 30 mg islatravir administered following ≥8 hour fast	Drug	Islatravir 30 mg, Islatravir 30 mg Extended Observation
0.5 mg islatravirAlso: MK-8591Single oral dose of 0.5 mg islatravir administered following ≥8 hour fast	Drug	Islatravir 0.5 mg
0.25 mg islatravirAlso: MK-8591Single oral dose of 0.25 mg islatravir administered following ≥8 hour fast	Drug	Islatravir 0.25 mg

Primary outcome

Change From Baseline in Plasma HIV-1 RNA at 168 Hours Post-Dose
Time frame: Baseline and 168 hours (7 days) post-dose
Plasma HIV-1 RNA was measured using the Roche COBAS Ampliprep/COBAS TaqMan HIV-1 test v.2.0, which has a linear range from 20 to 10,000,000 copies/mL. The lower limit of detection has 100% specificity at 20 copies/mL. Additionally, the test increases the probability of detection and expands coverage by targeting two highly conserved regions of the HIV-1 genome to compensate for the possibility of mutations or mismatches.
Number of Participants With One or More Adverse Events
Time frame: Up to 21 days post-dose
An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

9 secondary outcomes

Area Under the Concentration-Time Curve of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells From Time 0 to 168 Hours (AUC0-168hr)
Time frame: 4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.
Maximum Concentration (Cmax) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells
Time frame: 4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.
Concentration of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells at 168 Hours Post-Dose (C168hr)
Time frame: 168 hours after islatravir administration
Time to Maximum Concentration (Tmax) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells
Time frame: 4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.
Apparent Terminal Half-Life (t1/2) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells
Time frame: 4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.
Area Under the Plasma Concentration-Time Curve of Islatravir From Time 0 to 168 Hours (AUC0-168hr)
Time frame: Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration. Value at 168 hours was extrapolated.
Maximum Plasma Concentration (Cmax) of Islatravir
Time frame: Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration
Time to Maximum Plasma Concentration (Tmax) of Islatravir
Time frame: Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration
Apparent Terminal Half-Life (t1/2) of Islatravir in Plasma
Time frame: Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration

Results and safety

Results posted to the registry on 3 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Panel A: 10 mg Islatravir	6	6
Panel B: 2 mg Islatravir	6	6
Panel C: 30 mg Islatravir	6	6
Panel D: 1 mg Islatravir	6	6
Panel E: 0.5 mg Islatravir	6	6
Panel F: 0.25 mg Islatravir	0	0
Panel G: 30 mg Islatravir Extended Observation	0	0

Primary outcome: Change From Baseline in Plasma HIV-1 RNA at 168 Hours Post-Dose

Time frame: Baseline and 168 hours (7 days) post-dose. Least squares mean (95% Confidence Interval). Unit: log10 copies/mL

Measure	Panel A: 10 mg Islatravir n = 6	Panel B: 2 mg Islatravir n = 6	Panel C: 30 mg Islatravir n = 6	Panel D: 1 mg Islatravir n = 6	Panel E: 0.5 mg Islatravir n = 6
Value	-1.67 (-1.92 to -1.42)	-1.35 (-1.60 to -1.10)	-1.60 (-1.85 to -1.34)	-1.30 (-1.55 to -1.05)	-1.20 (-1.46 to -0.95)

Panel A: 10 mg Islatravir: Posterior mean difference: -1.64
Panel B: 2 mg Islatravir: Posterior mean difference: -1.32
Panel C: 30 mg Islatravir: Posterior mean difference: -1.57

Population analysed: The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had available plasma HIV-1 RNA data at baseline and 168 hours post-dose, and were evaluable for the outcome measure.

Primary outcome: Number of Participants With One or More Adverse Events

Time frame: Up to 21 days post-dose. Count of participants. Unit: Participants

Measure	Panel A: 10 mg Islatravir n = 6	Panel B: 2 mg Islatravir n = 6	Panel C: 30 mg Islatravir n = 6	Panel D: 1 mg Islatravir n = 6	Panel E: 0.5 mg Islatravir n = 6
Value	5	5	6	5	6

Population analysed: All participants who received at least one dose of investigational drug

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 21 days following administration of investigational drug. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Panel A: 10 mg Islatravir	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Panel B: 2 mg Islatravir	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Panel C: 30 mg Islatravir	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Panel D: 1 mg Islatravir	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Panel E: 0.5 mg Islatravir	0 of 6 (0%)	6 of 6 (100%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31911147Schurmann D, Rudd DJ, Zhang S, De Lepeleire I, Robberechts M, Friedman E, Keicher C, Huser A, Hofmann J, Grobler JA, Stoch SA, Iwamoto M, Matthews RP. Safety, pharmacokinetics, and antiretroviral activity of islatravir (ISL, MK-8591), a novel nucleoside reverse transcriptase translocation inhibitor, following single-dose administration to treatment-naive adults infected with HIV-1: an open-label, phase 1b, consecutive-panel trial. Lancet HIV. 2020 Mar;7(3):e164-e172. doi: 10.1016/S2352-3018(19)30372-8. Epub 2020 Jan 3.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 1 mg islatravir, 2 mg islatravir and 10 mg islatravir in people with HIV-1, run by Merck Sharp & Dohme LLC.

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 12 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 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 3 Dec 2018). 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?

Change From Baseline in Plasma HIV-1 RNA at 168 Hours Post-Dose (time frame: Baseline and 168 hours (7 days) post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02217904, which also lists 1 linked publication.

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 12 Aug 2019.