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Gsk3739937

Clinical trials are investigating Gsk3739937 in adults with HIV-1 infection. The study looks at antiviral activity, safety-related outcomes, and changes in plasma HIV-1 RNA in treatment-naive participants. It is a Phase 2 trial in a small group of adults.

Table of contents

Trial overview

This clinical trial studied Gsk3739937 in adults with HIV-1 infection.[1] The study title described it as a proof-of-concept trial, which means it was designed to see early signs of whether the treatment could work.[1] It was a Phase 2 interventional study and it has been completed.[1]

Who participated

The trial enrolled treatment-naive adults, meaning people who had not yet received treatment for HIV-1.[1] A total of 28 participants were enrolled.[1] This small group size fits an early study that is meant to look for a first signal of activity rather than to give a final answer for all patients.[1]

What was studied

The main goal was to evaluate the antiviral activity of Gsk3739937 during 7 days of monotherapy.[1] Antiviral activity means how well the study treatment can reduce the virus in the body.[1] Monotherapy means the study used one treatment only, so researchers could see the effect of Gsk3739937 more clearly.[1]

The trial compared active Gsk3739937 tablets with placebo tablets that looked the same but did not contain the active ingredient.[1] This kind of comparison helps researchers judge whether changes are due to the study drug and not to chance alone.[1]

Endpoints measured

The primary outcome was the maximum change from baseline in plasma HIV-1 RNA through Day 8.[1] Baseline means the starting point before treatment began.[1] Plasma HIV-1 RNA is the amount of virus genetic material in the blood, and it is a key way to measure how active the infection is.[1]

This outcome shows whether the virus level changed during the short study period after treatment started.[1] Because the study period was only 7 days of treatment with follow-up through Day 8, the trial was focused on early activity rather than long-term control.[1]

Trial design and treatment groups

The study was interventional, which means researchers assigned participants to treatment in a planned way.[1] The intervention list included oral Gsk3739937 and a matching placebo tablet.[1] Oral use means the tablets were taken by mouth.[1]

  • Active treatment: Participants received Gsk3739937 tablets by mouth, allowing researchers to study the drug’s effect on HIV-1 RNA levels.[1]
  • Placebo comparison: Some participants received placebo tablets that matched the active tablets in appearance but had no active ingredient.[1]
  • Short treatment period: The study evaluated effects over 7 days of monotherapy, with the main measurement through Day 8.[1]

What the results track

The trial data show the study was designed to answer an early research question: does Gsk3739937 change plasma HIV-1 RNA in treatment-naive adults with HIV-1 infection?[1] The completed Phase 2 design suggests the researchers were looking for proof-of-concept, or an early sign that the treatment may have antiviral activity.[1] The available trial record does not provide detailed outcome results in the source data used here.[1]

Trial ID Phase Condition studied Status Enrollment
2023-505780-37-00 Phase 2 HIV Infections Completed 28

FAQ

  • What is being studied in the Gsk3739937 trial? The trial is studying Gsk3739937 in adults with HIV-1 infection. It is looking at whether the treatment lowers plasma HIV-1 RNA over a short treatment period.
  • Who could take part in the study? The study focused on treatment-naive adults with HIV-1 infection. Treatment-naive means they had not yet received treatment for this infection.
  • What phase was the Gsk3739937 trial? This was a Phase 2 trial. Phase 2 studies usually look more closely at how well a treatment works and continue to collect safety information.
  • What was the main outcome measured? The main outcome was the maximum change from baseline in plasma HIV-1 RNA through Day 8. Baseline means the starting point before treatment.
  • Was a placebo used in the study? Yes. The trial included placebo tablets that looked like the active tablets but did not contain the active ingredient. This helps compare results more clearly.

Ongoing Clinical Trials on Gsk3739937

  • Study on the Effects of GSK3739937 for Adults with HIV-1 Who Have Not Yet Received Treatment

    Not recruiting

    2 1
    Investigated drugs:
    Greece Italy Poland Spain

Glossary

  • HIV-1: A type of human immunodeficiency virus. It is the infection studied in this trial.
  • HIV infection: An infection caused by the human immunodeficiency virus. The trial included adults with this condition.
  • Treatment-naive: A person who has not yet received treatment for the condition being studied.
  • Phase 2: A mid-stage clinical trial phase that looks more closely at whether a treatment works and continues to collect safety information.
  • Interventional study: A study where participants receive a treatment or placebo so researchers can compare results.
  • Placebo: A tablet that looks like the study drug but does not contain the active ingredient. It is used for comparison.
  • Monotherapy: Treatment with one study drug only, rather than combining several treatments.
  • Plasma HIV-1 RNA: The amount of HIV-1 genetic material in the blood. It is used to measure how active the infection is.
  • Baseline: The starting measurement taken before treatment begins.
  • Primary outcome: The main result the researchers planned to measure in the trial.

References

  1. https://clinicaltrials.gov/study/2023-505780-37-00