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A Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in in Treatment-Naive Adults Living With HIV-1

Sponsor
ViiV Healthcare (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06061081
Collaborator
(none)
26
Enrollment
19
Locations
2
Arms
8.8
Anticipated Duration (Months)
1.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary purpose of this study is to assess the antiviral activity of VH3739937 in Human Immunodeficiency Virus Type-1 (HIV-1) infected treatment naive (TN) participants during monotherapy.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind (Sponsor-Unblinded), Placebo-Controlled, Adaptive Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in Treatment-Naïve Adults Living With HIV-1
Anticipated Study Start Date :
Oct 3, 2023
Anticipated Primary Completion Date :
Jun 26, 2024
Anticipated Study Completion Date :
Jun 26, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Participants receiving VH3739937

Drug: VH3739937
VH3739937 will be administered.
Placebo Comparator: Participants receiving Placebo

Drug: Placebo
Placebo will be administered.

Outcome Measures

Primary Outcome Measures

  1. Maximum Change from Baseline in Plasma HIV-1 Ribonucleic Acid (RNA) [Baseline (Day 1) and up to Day 8]

Secondary Outcome Measures

  1. Number of Participants with Serious Adverse Events, Deaths, or Adverse Events leading to Discontinuation [Up to Day 8]

  2. Maximum observed concentration of VH3739937 at Day 1 [Day 1]

  3. Time to maximum observed concentration (Tmax) of VH3739937 at Day 1 [Day 1]

  4. Concentration at 24 hours (h) post dose of VH3739937 at Day 1 [Day 1]

  5. Area under the concentration-time curve from zero to 24h of VH3739937 at Day 1 [Day 1]

  6. Maximum observed concentration of VH3739937 at steady state [Day 7]

  7. Time to maximum observed concentration (Tmax) of VH3739937 at steady state [Day 7]

  8. Concentration at 24 h post dose of VH3739937 at steady state [Day 7]

  9. Area under the concentration-time curve from zero to 24h of VH379937 at steady state [Day 7]

  10. Maximum observed concentration of VH3739937 after single dose [Up to 168 hours]

  11. Time to maximum observed concentration (Tmax) of VH3739937 after single dose [Up to 168 hours]

  12. Area under the concentration-time curve of VH3739937 from zero to 168h after single dose [Up to 168 hours]

  13. Concentration of VH3739937 at 168 h after single dose [At 168 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Participants who are overtly healthy (other than HIV infection) as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring

  • Positive HIV antibody test

  • Treatment-naïve: No Antiretrovirals (ARVs) (in combination or monotherapy) received after the diagnosis of HIV-1 infection

  • Body weight ≥50.0 kilogram (kg) (110 pounds [lbs]) for men and ≥45.0 kg (99 lbs) for women and BMI for all participants within the range 18.5-35.0 kilogram per meter square (kg/m^2).

  • Capable of giving signed informed consent

  • Participant must be willing and able to start Combination Antiretrovial Therapy (cART) as selected with the Investigator on Study Day 8 (except in the case of early termination, clinically relevant AE/SAE, lab abnormality, the withdrawal of consent, lost to follow-up, etc., where circumstances could dictate otherwise).

Exclusion Criteria:

  • Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)

  • Participants with primary HIV infection, evidenced by acute retroviral syndrome (e.g., fever, malaise, fatigue, etc) and/or evidence of recent (within 3 months) documented viremia without antibody production and/or evidence of recent (within 3 months) documented seroconversion

  • Myocardial infarction, acute coronary syndrome, unstable angina, stroke, transient ischemic attack, or intermittent claudication in the past 3 months

  • The participant has received an investigational HIV vaccine (immunotherapeutic or immunomodulatory)

  • Regular use of drugs of abuse

  • Sensitivity to heparin or heparin-induced thrombocytopenia

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Bakersfield California United States 93301
2 GSK Investigational Site Miami Florida United States 33136
3 GSK Investigational Site West Palm Beach Florida United States 33401
4 GSK Investigational Site Newark New Jersey United States 07102
5 GSK Investigational Site Santa Fe New Mexico United States 87505
6 GSK Investigational Site Dallas Texas United States 75246
7 GSK Investigational Site Ciudad Autonoma de Buenos Aires Buenos Aires Argentina C1181ACH
8 GSK Investigational Site Villa María Cordoba Argentina X5900
9 GSK Investigational Site Cordoba Córdova Argentina X5016KEH
10 GSK Investigational Site Rosario Santa Fe Argentina 2000
11 GSK Investigational Site Athens Greece 10676
12 GSK Investigational Site Athens Greece 12462
13 GSK Investigational Site Modena Emilia Romagna Italy 41124
14 GSK Investigational Site Roma Lazio Italy 00133
15 GSK Investigational Site Genova Liguria Italy 16132
16 GSK Investigational Site Brescia Lombardia Italy 25123
17 GSK Investigational Site Milano Italy 20142
18 GSK Investigational Site Szczecin Poland 71- 455
19 GSK Investigational Site Warszawa Poland 01-201

Sponsors and Collaborators

  • ViiV Healthcare

Investigators

  • Study Director: GSK Clinical Trials, ViiV Healthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT06061081
Other Study ID Numbers:
  • 212580
  • 2023-505780-37-00
First Posted:
Sep 29, 2023
Last Update Posted:
Sep 29, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by ViiV Healthcare
VH3739937
Treatment Naïve
HIV-1
Additional relevant MeSH terms:
HIV Infections

Study Results

No Results Posted as of Sep 29, 2023