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AzTrials

HIV InfectionsPhase 1NCT06533280

VH3739937 Phase 1 Multiple Ascending Dose (MAD) Study in Healthy Volunteers Including Relative Bioavailability (RBA), Optional Food Effect (FE), and Drug-drug Interaction (DDI)

A Phase 1 study testing Part A, C and D: VH3739937 500 mg, Part A: VH3739937 100 mg and Part B: Treatment A in people with HIV Infections, run by ViiV Healthcare at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study will assess safety, tolerability and pharmacokinetic (PK) of VH3739937 in healthy participants. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
Part A, C and D: VH3739937 500 mg, Part A: VH3739937 100 mg and Part B: Treatment A
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
2 Aug 2024to 14 Aug 2024
Phase
Phase 1
Are there results?
None posted in the registry

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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participants who are overtly healthy as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and ECG).
  • Participants who can understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions.
  • Age
  • Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
  • Weight
  • Body weight >=50.0 kg (110 lbs) for men and >=45.0 kg (99 lbs) for women, and BMI within the range 18.5 to 32.0 kg/m2 (inclusive).
Show all 21Show fewer
  • Sex
  • Participants male at birth and participants female at birth:
  • Participants male at birth:
  • Participants male at birth are eligible to participate if they agree to the following during the study intervention period and for at least 90 days (a spermatogenesis cycle) after the last dose of study intervention:
  • Refrain from donating sperm
  • PLUS either:
  • Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.
  • OR
  • Must agree to use contraception as detailed below: Agree to use a male condom and, if their partner is a person who is able to become pregnant, and who is not currently pregnant, they should also be advised of the benefit for their partner to use a highly effective method of contraception when having sexual intercourse, as a condom may break or leak.
  • Participants female at birth:
  • A participant who was female at birth is eligible to participate if they are not pregnant or breast- / chest- feeding, and one of the following conditions applies:
  • They are a PONCBP as defined in Section 10.4 Contraception and barrier guidance.
  • The Investigator is responsible for review of medical history, menstrual history/postmenopausal status, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
  • Informed consent
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.

Who cannot join

  • Medical conditions
  • History or presence of cardiovascular, respiratory, hepatic, renal, GI, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
  • Unstable liver disease known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per Investigator assessment).
  • Known history of cirrhosis with or without viral hepatitis co-infection.
  • History of clinically relevant hepatitis within last 6 months.
  • Patients with chronic hepatitis B (HBsAg positive) infection (see HBV diagnostic criteria described below and in the study laboratory manual).
Show all 45Show fewer
  • Have a history of malignant neoplasm (excepting definitively treated non-melanoma skin cancer or carcinoma in situ of the uterine cervix, which may be enrolled at any time) within the last 5 years.
  • Clinically significant cardiovascular disease.
  • A sustained semi-supine systolic blood pressure >150 mm Hg or <90 mm Hg or a semi-supine diastolic blood pressure >95 mm Hg or <50 mm Hg at Screening or Check-in.
  • A resting HR of <50 bpm or >100 bpm when vital signs are measured at Screening or Check-in. A HR from 100 bpm to 110 bpm can be rechecked by ECG or vital signs within up to 2 hours to verify eligibility.
  • An uninterpretable ECG or any significant arrhythmia or ECG finding which, in the opinion of the Investigator or VH/GSK Medical Monitor, will interfere with the safety of the individual participant.
  • Abnormalities on Screening ECG is allowed for eligibility determination: QTcF > 450 msec., QRS > 120 msec, PR > 220 msec
  • Any history of significant underlying psychiatric disorder, in the opinion of the Investigator or Medical Monitor; or a clinical assessment of suicidality based on the responses on the C-SSRS (Columbia Suicidality Scale). Participants' history of suicidal behaviour and/or suicidal ideation should be considered when evaluating for suicide risk.
  • Any history of major depressive disorder with or without suicidal features, or anxiety disorders that required medical intervention such as hospitalization or other inpatient treatment and/or chronic (>6 months) outpatient treatment. Participants with other conditions such as adjustment disorder or dysthymia that have required shorter term medical therapy (<6 months) without inpatient treatment and are currently well-controlled clinically or resolved may be considered for entry after discussion and agreement with the VH/GSK Medical Monitor.
  • Any pre-existing physical or other psychiatric condition which could interfere with the participant's ability to comply with the dosing schedule and protocol evaluations or which might compromise the safety of the participant.
  • Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • A pre-existing condition, that could interfere with normal GI anatomy or motility hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study interventions or render the participant unable to take oral study intervention.
  • Prior/Concomitant therapy
  • Past or intended use of over-the-counter or prescription medication within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to dosing and for the duration of the study.
  • Use of narrow therapeutic index drugs that are substrates of P-gp or CYP3A are not permitted during the study.
  • Participants receiving any protocol-prohibited medication and who are unwilling or unable to switch to an alternate medication.
  • Prior/Concurrent clinical study experience
  • Participation in the clinical study would result in loss of blood or blood products in excess of 500 mL within 56 days.
  • Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
  • Current enrollment or past participation in another investigational clinical study in which an investigational intervention was administered within the last either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent.
  • Past or current enrollment or past participation in earlier parts of this clinical study.
  • Diagnostic assessments
  • Positive pre-enrollment clinical study drug/alcohol screen, including tetrahydrocannabinol.
  • Positive HIV fourth generation test.
  • Urine cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to Screening and at admission.
  • Any acute laboratory abnormality at Screening, which would preclude the participant's participation in the study of an investigational compound.
  • Any verified Grade 4 laboratory abnormality.
  • ALT >1.5 ULN or total bilirubin >1.5 ULN. Participants with Gilbert's syndrome can be included with total bilirubin >1.5xULN as long as direct bilirubin is <1.5xULN.
  • eGFR of <60 mL/min/1.73 m2 via CKD-EPI [Delgado, 2022].
  • Presence of HBsAg at Screening or within 3 months prior to first dose of study intervention.
  • Positive hepatitis C antibody test result at Screening or within 3 months prior to first dose of study intervention.
  • Positive hepatitis C RNA test result at Screening or within 3 months prior to first dose of study intervention.
  • Other exclusion criteria
  • Regular alcohol consumption within 6 months prior to the clinical study.
  • Regular use of known drugs of abuse, including tetrahydrocannabinol.
  • Regular use of combustible tobacco products, and non-combustible nicotine delivery systems.
  • Sensitivity to heparin or heparin-induced thrombocytopenia.
  • Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that contraindicates participation in the clinical study.
  • Use of any products intended to treat medical conditions that are not approved by the governing health authority in a given country or region.
  • To assess any potential impact on participant eligibility with regard to safety, the Investigator must refer to the IB and supplements, approved product labels, and/or local prescribing information for detailed information regarding warnings, precautions, contraindications, AEs, drug interactions, and other significant data pertaining to the study drugs.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • GSK Investigational Site

    Baltimore, Maryland, 21225

Other trials in United States

About this study

Official title: A Multi-part Phase 1 Study Assessing the Safety, Tolerability, and PK of VH3739937 in Healthy Participants, by Conducting MAD and RBA Cohorts, With Optional Food Effect and Drug Interaction Cohorts

This study will assess safety, tolerability and pharmacokinetic (PK) of VH3739937 in healthy participants.

Conditions
HIV Infections
Being tested
Part A, C and D: VH3739937 500 mg, Part A: VH3739937 100 mg, Part A and C: Placebo, Part B: Treatment A, Part B: Treatment B
Keywords
VH3739937, Multiple ascending dose, Relative bioavailability, Food effect, Drug-drug interaction
Medical subject headings
HIV Infections

What participants receive

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

  • Part A, C and D: VH3739937 500 mgDrug

    Oral administration of VH3739937 in moderate fat/moderate calorie conditions

  • Part A: VH3739937 100 mgDrug

    Oral administration of VH3739937 in moderate fat/moderate calorie conditions.

  • Part A and C: PlaceboDrug

    Oral administration of Placebo in moderate fat/moderate calorie conditions

  • Part B: Treatment ADrug

    VH3739937, 500 mg(single dose given as 5 x 100 mg tablets). administered under moderate fat/moderate calorie conditions (reference)

  • Part B: Treatment BDrug

    VH3739937, 500 mg (single dose given as 500 mg tablet) administered under moderate fat/moderate calorie conditions (test)

  • Part B: Treatment CDrug

    VH3739937, 500 mg single tablet administered under fasted conditions.

  • Part B: Treatment DDrug

    VH3739937, 500 mg single tablet administered under low-fat/ low calorie conditions.

  • Part B: Treatment EDrug

    VH3739937, 500 mg single tablet administered under high-fat/ high calorie conditions.

  • Part D: Probe cocktailDrug

    Oral administration of probe cocktail (Midazolam, Digoxin, Total Dabigatran etexilate, Rosuvastatin) in moderate fat/moderate calorie conditions.

Study groups in NCT06533280
Study groupRoleWhat they receive
Part A MAD: VH3739937ExperimentalPart A MAD: VH3739937 group will contain 3 ascending repeat-dose cohorts (Cohorts A1- A3), where participants will receive a twice daily (BID) dose of VH3739937 for 1 (Cohort A1), 2 (Cohort A2) or 3 (Cohort A3) days in fed conditions.
Receives: Drug: Part A, C and D: VH3739937 500 mg; Drug: Part A: VH3739937 100 mg
Part A MAD: PlaceboPlacebo comparatorPart A MAD: Placebo group will include participants that will receive BID dose of placebo in fed conditions
Receives: Drug: Part A and C: Placebo
Part B RBA/ optional FE: VH3739937ExperimentalPart B RBA/FE: VH3739937 group will include participants that will receive treatment sequences (Treatment AB or BA) alternatively in Period 1 and Period 2 of the treatment. In Period 3 and Period 4, participants will receive 1 of 6 treatment sequences (CD, CE, ED, EC, DE, DC) in fed or fasted conditions.
Receives: Drug: Part B: Treatment A; Drug: Part B: Treatment B; Drug: Part B: Treatment C; Drug: Part B: Treatment D; Drug: Part B: Treatment E
Part C: Optional QW VH3739937ExperimentalParticipants in this group will receive a weekly administration (QW) of VH3739937 during a 3-week period in fed conditions.
Receives: Drug: Part A, C and D: VH3739937 500 mg
Part C: Optional QW PlaceboPlacebo comparatorParticipants in this group will receive a weekly administration (QW) of placebo during a 3-week period in fed conditions.
Receives: Drug: Part A, C and D: VH3739937 500 mg; Drug: Part A and C: Placebo
Part D: Optional DDIExperimentalParticipants in this group will receive a dose of the probe cocktail (Midazolam, Digoxin, Total Dabigatran etexilate, Rosuvastatin) alone on Day 1, followed by a subsequent dose of probe cocktail together with a single dose of VH3739937 on Day 10, in fed conditions.
Receives: Drug: Part A, C and D: VH3739937 500 mg; Drug: Part D: Probe cocktail

What is being measured

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

  1. Part A: Number of participants with any adverse events (AEs)

    Measured: Up to Day 25 for Cohorts A1 and A2 and Day 30 for Cohort A3

  2. Part B: Number of participants with any adverse events (AEs)

    Measured: Up to Day 15

  3. Part C: Number of participants with any adverse events (AEs)

    Measured: Up to Day 42

  4. Part D: Number of participants with any adverse events (AEs)

    Measured: Up to Day 28

  5. Part A: Number of participants with adverse events (AEs) by grade of severity

    The severity grade is defined as following: Grade 1= mild, Grade 2=moderate, Grade 3=severe, Grade 4=potentially life-threatening.

    Measured: Up to Day 25 for Cohorts A1 and A2, and Day 30 for Cohort A3

  6. Part B: Number of participants with adverse events (AEs) by grade of severity

    The severity grade is defined as following: Grade 1= mild, Grade 2=moderate, Grade 3=severe, Grade 4=potentially life-threatening.

    Measured: Up to Day 15 (Periods 2 and 4 only)

  7. Part C: Number of participants with adverse events (AEs) by grade of severity

    The severity grade is defined as following: Grade 1= mild, Grade 2=moderate, Grade 3=severe, Grade 4=potentially life-threatening.

    Measured: Up to Day 42

  8. Part D: Number of participants with adverse events (AEs) by grade of severity

    The severity grade is defined as following: Grade 1= mild, Grade 2=moderate, Grade 3=severe, Grade 4=potentially life-threatening.

    Measured: Up to Day 28

  9. Part A: Number of participants with any serious adverse events (SAEs)

    Measured: Up to Day 25 for Cohort A1 and A2 and Day 30 for Cohort A3

  10. Part B: Number of participants with any serious adverse events (SAEs)

    Measured: Up to Day 15 (Periods 2 and 4 only)

  11. Part C: Number of participants with any serious adverse events (SAEs)

    Measured: Up to Day 42

  12. Part D: Number of participants with any serious adverse events (SAEs)

    Measured: Up to Day 28

  13. Part A: Number of participants with serious adverse events (SAEs) by grade of severity

    The severity grade is defined as following: Grade 1= mild, Grade 2=moderate, Grade 3=severe, Grade 4=potentially life-threatening.

    Measured: Up to Day 25 for Cohort A1 and A2, and Day 30 for Cohort A3

  14. Part B: Number of participants with serious adverse events (SAEs) by grade of severity

    The severity grade is defined as following: Grade 1= mild, Grade 2=moderate, Grade 3=severe, Grade 4=potentially life-threatening.

    Measured: Up to Day 15 (Periods 2 and 4 only)

  15. Part C: Number of participants with serious adverse events (SAEs) by grade of severity

    The severity grade is defined as following: Grade 1= mild, Grade 2=moderate, Grade 3=severe, Grade 4=potentially life-threatening.

    Measured: Up to Day 42

  16. Part D: Number of participants with serious adverse events (SAEs) by grade of severity

    The severity grade is defined as following: Grade 1= mild, Grade 2=moderate, Grade 3=severe, Grade 4=potentially life-threatening.

    Measured: Up to Day 28

  17. Part B: Area under the plasma concentration over a dosing interval from time of dosing to the time of the subsequent dose (AUC[0-t])

    Measured: At Days 1 2, 3, 4, 6, 8, 12, 15 (Period 2 and Period 3 only)

  18. Part B: AUC time curve from time zero to infinity (AUC[0-infinity])

    Measured: At Days 1 2, 3, 4, 6, 8, 12, 15 (Period 2 and Period 3 only)

  19. Part B: Time to maximum observed plasma concentration (Tmax)

    Measured: At Days 1 2, 3, 4, 6, 8, 12, 15 (Period 2 and Period 3 only)

  20. Part B: Maximum observed plasma concentration (Cmax) after VH3739937 administration

    Measured: At Days 1 2, 3, 4, 6, 8, 12, 15 (Period 2 and Period 3 only)

Secondary outcomes (32)

  1. Part B: AUC to the end of the dosing period (AUC[0-tau]) after VH3739937 administration

    Measured: At Days 1, 2, 3, 4, 6, 8, 12, 15 (Period 2 and Period 3 only)

  2. Part B: AUC[0-infinity] after VH3739937 administration

    Measured: At Days 1, 2, 3, 4, 6, 8, 12, 15 (Period 2 and Period 3 only)

  3. Part B: Tmax after VH3739937 administration

    Measured: At Days 1, 2, 3, 4, 6, 8, 12, 15 (Period 2 and Period 3 only)

  4. Part B: Apparent terminal half-life (T1/2) after VH3739937 administration

    Measured: At Days 1, 2, 3, 4, 6, 8, 12, 15 (Period 2 and Period 3 only)

  5. Part B: Apparent Oral Clearance (CL/F) after VH3739937 administration

    Measured: At Days 1, 2, 3, 4, 6, 8, 12, 15 (Period 2 and Period 3 only)

  6. Part D: AUC[0-tau] after VH3739937 administration

    Measured: At Day 10 and Day 11

  7. Part D: AUC[0-infinity] after VH3739937 administration

    Measured: At Day 10 and Day 11

  8. Part D: Cmax after VH3739937 administration

    Measured: At Day 10 and Day 11

  9. Part D: Tmax after VH3739937 administration

    Measured: At Day 10 and Day 11

  10. Part D: T1/2 after VH3739937 administration

    Measured: At Day 10 and Day 11

  11. Part D: CL/F after VH3739937 administration

    Measured: At Day 10 and Day 11

  12. Part A: AUC[0-tau] after VH3739937 administration

    Measured: At Days 1 to 6, 8, 11, 15, 20, 25 (Cohort A1), at Days 1, 3 to 9, 11, 15, 20, 25 (Cohort A2), at Days 1, 4 to 8 , 10, 14, 18, 25, Day 30 (Cohort A3)

  13. Part A: Cmax after VH3739937 administration

    Measured: At Days 1 to 6, 8, 11, 15, 20, 25 (Cohort A1), at Days 1, 3 to 9, 11, 15, 20, 25 (Cohort A2), at Days 1, 4 to 8 , 10, 14, 18, 25, Day 30 (Cohort A3)

  14. Part A: Tmax after VH3739937 administration

    Measured: At Days 1 to 6, 8, 11, 15, 20, 25 (Cohort A1), at Days 1, 3 to 9, 11, 15, 20, 25 (Cohort A2), at Days 1, 4 to 8 , 10, 14, 18, 25, Day 30 (Cohort A3)

  15. Part A: T1/2 after VH3739937 administration

    Measured: At Days 1 to 6, 8, 11, 15, 20, 25 (Cohort A1), at Days 1, 3 to 9, 11, 15, 20, 25 (Cohort A2), at Days 1, 4 to 8 , 10, 14, 18, 25, Day 30 (Cohort A3)

  16. Part C: AUC[0-tau] after VH3739937 administration

    Measured: At Days 1, 2, 5, 7, 8, 9, 13, 15, 16, 17, 26, 34 and 42

  17. Part C: Concentration in a dosing interval (Ctau) after VH3739937 administration

    Measured: At Days 1, 2, 5, 7, 8, 9, 13, 15, 16, 17, 26, 34 and 42

  18. Part C: Cmax after VH3739937 administration

    Measured: At Days 1, 2, 5, 7, 8, 9, 13, 15, 16, 17, 26, 34 and 42

  19. Part C: Tmax after VH3739937 administration

    Measured: At Days 1, 2, 5, 7, 8, 9, 13, 15, 16, 17, 26, 34 and 42

  20. Part C: T1/2 after VH3739937 administration

    Measured: At Days 1, 2, 5, 7, 8, 9, 13, 15, 16, 17, 26, 34 and 42

  21. Part C: CL/F after VH3739937 administration

    Measured: At Days 1, 2, 5, 7, 8, 9, 13, 15, 16, 17, 26, 34 and 42

  22. Part D: AUC[0-infinity] after probe cocktail administration

    Measured: At Day 10 and Day 11

  23. Part D: Cmax after probe cocktail administration

    Measured: At Day 10 and Day 11

  24. Part D: Tmax after probe cocktail administration

    Measured: At Day 10 and Day 11

  25. Part D: T1/2 after probe cocktail administration

    Measured: At Day 10 and Day 11

  26. Part D: CL/F after probe cocktail administration

    Measured: At Day 10 and Day 11

  27. Change from baseline for heart rate over all study groups

    Measured: Up to Day 25 for Part A (Cohort A1 and A2) and Day 30 (Cohort A3), Day 15 for Part B, Day 17 and Day 42 for Part C, Day 14 and Day 28 for Part D

  28. Change from baseline in PR Interval, QRS Interval, and QT Interval corrected for heart rate using Fridericias formula (QTcF) over all study groups

    Measured: At Days (D) 1 to 5, 8, 15, 25 for Cohort A1 (Part A), D 1 to 6, 9, 15, 25 for Cohort A2 (Part A), D 1 to 7, 10, 18, 30 for Cohort A3 (Part A), at D 1, 3, 6, 12,15 for Part B, at D 1, 2, 8, 9, 13 to 17, 42 for Part C, at D 1, 3, 10, 14, 28 for Part D

  29. Placebo-corrected change from baseline heart rate over alll study groups

    Measured: At Days (D) 1 to 5, 8, 15, 25 for Cohort A1 (Part A), D 1 to 6, 9, 15, 25 for Cohort A2 (Part A), D 1 to 7, 10, 18, 30 for Cohort A3 (Part A), at D 1, 3, 6, 12,15 for Part B, at D 1, 2, 8, 9, 13 to 17, 42 for Part C, at D 1, 3, 10, 14, 28 for Part D

  30. Placebo-corrected change from baseline in PR Interval, QRS Interval, and QT Interval corrected for heart rate using Fridericias formula (QTcF) over all study groups

    Measured: At Days (D) 1 to 5, 8, 15, 25 for Cohort A1 (Part A), D 1 to 6, 9, 15, 25 for Cohort A2 (Part A), D 1 to 7, 10, 18, 30 for Cohort A3 (Part A), at D 1, 3, 6, 12,15 for Part B, at D 1, 2, 8, 9, 13 to 17, 42 for Part C, at D 1, 3, 10, 14, 28 for Part D

  31. Categorical outliers for heart rate, PR Interval, QRS Interval and QT Interval over all study groups

    Measured: At Days (D) 1 to 5, 8, 15, 25 for Cohort A1 (Part A), D 1 to 6, 9, 15, 25 for Cohort A2 (Part A), D 1 to 7, 10, 18, 30 for Cohort A3 (Part A), at D 1, 3, 6, 12,15 for Part B, at D 1, 2, 8, 9, 13 to 17, 42 for Part C, at D 1, 3, 10, 14, 28 for Part D

  32. Frequency of treatment-emergent electrocardiogram (ECG) morphology changes over all study groups

    Measured: At Days (D) 1 to 5, 8, 15, 25 for Cohort A1 (Part A), D 1 to 6, 9, 15, 25 for Cohort A2 (Part A), D 1 to 7, 10, 18, 30 for Cohort A3 (Part A), at D 1, 3, 6, 12,15 for Part B, at D 1, 2, 8, 9, 13 to 17, 42 for Part C, at D 1, 3, 10, 14, 28 for Part D

Timeline

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

  1. First posted1 Aug 2024
  2. Study start2 Aug 2024
  3. Primary completion14 Aug 2024
  4. Study completion14 Aug 2024

Why it stopped: Sponsor decision

Resources

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
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06533280
Sponsor's protocol ID
221773
Status last verified
Apr 2025
First submitted
29 Jul 2024
Last updated
22 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Part A, C and D: VH3739937 500 mg, Part A: VH3739937 100 mg and Part B: Treatment A in people with HIV Infections, run by ViiV Healthcare at 1 site in United States.

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 21 inclusion and 45 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: withdrawn, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Part A: Number of participants with any adverse events (AEs) (time frame: Up to Day 25 for Cohorts A1 and A2 and Day 30 for Cohort A3). The study lists 20 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 NCT06533280.

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 22 Apr 2025.

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