A Phase 1 interventional study of VH4011499 and [14C]-VH4011499 (IV) in HIV Infections, sponsored by ViiV Healthcare. Not yet recruiting. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by ViiV Healthcare (part of GlaxoSmithKline) · Phase 1, Interventional, and Basic science
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Among 265 studies in HIV Infections by GlaxoSmithKline — 14 open to participants now, 26 under way, 8 of them phase 3. HIV Infections · GlaxoSmithKline.
Among the 265 studies in HIV Infections by GlaxoSmithKline, this one is the 183rd largest by planned enrollment of the 209 interventional ones that give a count, is one of 9 that started in 2026, is one of 82 in phase 1, reaches primary completion later than 13 of the 25 other live ones, and was the 265th registered.
4,736 studies on the registry are indexed under HIV Infections; 246 are open to participants now.
Browse HIV Infections studies →14 of the 265 studies in HIV Infections by GlaxoSmithKline are open now, in 12 countries. Recruiting first, the newest first:
ViiV Healthcare · Sites in United States
Ages 18–55 · Healthy volunteers
ViiV Healthcare · Sites in Romania, South Africa, Uganda
ViiV Healthcare · Sites in Netherlands
Ages 18–55 · Healthy volunteers
ViiV Healthcare · Sites in United States
Ages 18–55 · Healthy volunteers
ViiV Healthcare · Sites in South Africa
Ages up to 10 days · Healthy volunteers
By country, each count listing its studies:
Of the 159 HIV Infections studies recruiting now, 104 (65%) set no upper age limit and 42 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.
This study: 18 Years to 55 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
265 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 84 · Phase 2 53 · Phase 3 68 · Phase 4 18
First in 1994; this study’s year is marked. 9 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 18 is below the median of 80 across 3,491 interventional studies indexed under HIV Infections.
Median enrollment 84 across the 209 interventional studies, 328 across the 14 observational. Of the 230 that completed or were terminated, 95 (41%) have results posted.
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This study is registered under ViiV Healthcare, one of the names counted as GlaxoSmithKline. Under that name alone:
ViiV Healthcare is the lead sponsor of 266 studies on the registry; 17 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 53 (75%) have results posted.
5 of the studies in HIV Infections by GlaxoSmithKline that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07053384ViiV HealthcareA Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV | 2027-01-22 |
| NCT07934719ViiV HealthcareMass Balance and Absolute Bioavailability of [14C]-VH4011499 | 2027-02-18 |
| NCT06786520ViiV HealthcareA Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Cabotegravir Ultra Long-acting (CAB ULA) Following Switch From Cabotegravir Long-acting (CAB LA) in Healthy Adults | 2027-03-08 |
| NCT07525544ViiV HealthcareA Study to Investigate the Safety and PK of VH4770359 in Healthy Participants | 2027-05-05 |
| NCT07202546ViiV HealthcareA Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) | 2027-10-28 |
Add all 5 to your calendar (.ics) → With an account.
Among the 265 studies in HIV Infections by GlaxoSmithKline, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of the trial is to characterize the absorption, metabolism, and excretion of [14C]-VH4011499, and to evaluate the absolute bioavailability of VH4011499.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Female participants are eligible to participate if they are of non-childbearing potential and are not breastfeeding or planning to breastfeed for at least 12 months following the last dose.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a single oral dose of VH4011499, followed by a single intravenous (iv) microtracer dose of \[14C\]-VH4011499.
Drug: VH4011499 · Drug: [14C]-VH4011499 (IV)
Participants will receive a single oral dose of \[14C\]-VH4011499.
Drug: [14C]-VH4011499 (oral)
VH4011499 will be administered orally.
\[14C\]-VH4011499 will be administered as an iv infusion.
\[14C\]-VH4011499 will be administered orally.
Total Radioactivity (TRA) of the Cumulative Amount of Drug Excreted in Urine (Ae urine)
Urine is collected until the cumulative amount of radioactivity recovered in excreta (urine and feces) is at least 90% of the administered radioactivity and less than 1% of the administered radioactive dose is recovered during a 24-hour collection period on 2 consecutive collection days.
Time frame: Up to 70 days
TRA of the Cumulative Amount of Drug Excreted in Feces (Ae feces)
Feces are collected until the cumulative amount of radioactivity recovered in excreta (urine and feces) is at least 90% of the administered radioactivity and less than 1% of the administered radioactive dose is recovered during a 24-hour collection period on 2 consecutive collection days.
Time frame: Up to 70 days
Cohort 2 Only: TRA of the Cumulative Amount of Drug Excreted in Vomitus (Ae vomit)
Vomitus (if applicable) will be collected and included in the assessment until the cumulative amount of radioactivity recovered in excreta is at least 90% of the administered radioactivity and less than 1% of the administered radioactive dose is recovered.
Time frame: Up to 70 days
TRA of the Total Amount of Drug Excreted (Ae total)
Total amount of TRA excreted in excreta, calculated as the sum of the cumulative amount of radioactivity recovered in urine, feces, and vomit (if collected). Urine, feces, and vomitus (if applicable) will be collected until the cumulative amount of radioactivity recovered in excreta is at least 90% of the administered radioactive dose and less than 1% of the administered radioactive dose is recovered during a 24-hour collection period on 2 consecutive collection days.
Time frame: Up to 70 days
Fraction of the Administered Radiolabeled Dose Excreted in Urine (fe urine) as Total Drug Related Material
Fraction of the dose administered excreted (unchanged) in urine percentage. Urine is collected until the cumulative amount of radioactivity recovered in excreta (urine and feces) is at least 90% of the administered radioactivity and less than 1% of the administered radioactive dose is recovered during a 24-hour collection period on 2 consecutive collection days.
Time frame: Up to 70 days
Cohort 2 Only: Fraction of the Administered Radiolabeled Dose Excreted in Feces (fe feces) as Total Drug Related Material
Fraction of the dose administered excreted in feces percentage. Feces are collected until the cumulative amount of radioactivity recovered in excreta (urine and feces) is at least 90% of the administered radioactivity and less than 1% of the administered radioactive dose is recovered during a 24-hour collection period on 2 consecutive collection days.
Time frame: Up to 70 days
Cohort 2 Only: Fraction of the Administered Radiolabeled Dose Excreted in Vomitus (fe vomit) as Total Drug Related Material
Fraction of the dose administered excreted in vomitus percentage. Vomitus (if applicable) will be collected and included in the assessment until the cumulative amount of radioactivity recovered in excreta is at least 90% of the administered radioactivity and less than 1% of the administered radioactive dose is recovered.
Time frame: Up to 70 days
Fraction of the Administered Radiolabeled Dose Excreted in Urine, Feces, and Vomitus (fe total) as Total Drug Related Material
Fraction of the dose administered excreted in urine, feces, and vomitus if applicable percentage. Urine, feces, and vomitus (if applicable) will be collected until the cumulative amount of radioactivity recovered in excreta is at least 90% of the administered radioactive dose and less than 1% of the administered radioactive dose is recovered during a 24-hour collection period on 2 consecutive collection days.
Time frame: Up to 70 days
Maximum Observed Plasma Concentration (Cmax) of VH4011499
Time frame: Up to 70 days
Time to Attain Cmax (tmax) of VH4011499
Time frame: Up to 70 days
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of VH4011499
Time frame: Up to 70 days
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of VH4011499
Time frame: Up to 70 days
Cohort 1 Only: Cmax of [14C]-VH4011499
Time frame: Up to 70 days
Cohort 1 Only: Tmax of [14C]-VH4011499
Time frame: Up to 70 days
Cohort 1 Only: AUC0-t of [14C]-VH4011499
Time frame: Up to 70 days
Cohort 1 Only: AUC0-inf of [14C]-VH4011499
Time frame: Up to 70 days
Cmax of TRA in Plasma
Time frame: Up to 70 days
Tmax of TRA in Plasma
Time frame: Up to 70 days
AUC0-t of TRA in Plasma
Time frame: Up to 70 days
AUC0-inf of TRA in Plasma
Time frame: Up to 70 days
Cmax of TRA in Whole Blood
Time frame: Up to 70 days
Tmax of TRA in Whole Blood
Time frame: Up to 70 days
AUC0-t of TRA in Whole Blood
Time frame: Up to 70 days
AUC0-inf of TRA in Whole Blood
Time frame: Up to 70 days
Whole Blood-to-plasma Ratio of TRA
Cmax, AUC(0-t) and AUC(0-inf) TRA measured in whole blood compared to Cmax, AUC(0-t) and AUC(0-inf) TRA measured in plasma.
Time frame: Up to 70 days
Cohort 2 Only: Ae urine of VH4011499
Time frame: Up to 70 days
Cohort 2 Only: fe urine of VH4011499
Fraction of the dose administered excreted (unchanged) in urine percentage.
Time frame: Up to 70 days
Cohort 2 Only: Renal clearance (CLR) of VH4011499
Time frame: Up to 70 days
Number of Participants with Adverse Events (AEs) by Severity
Time frame: Up to 77 days
Absolute Values of Total Bilirubin, Direct bilirubin, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT)
Time frame: Up to 77 days
Change From Baseline in Total Bilirubin, Direct Bilirubin, ALP, AST, and ALT
Time frame: Up to 77 days
Maximum Toxicity Grade Change From Baseline in Total Bilirubin, Direct Bilirubin, ALP, AST, and ALT
Time frame: Up to 77 days
Cohort 1 Only: Absolute Oral Bioavailability (F oral) of VH4011499
Time frame: Up to 70 days
No study locations are listed for this record.
Plan to share: Yes — Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About_ViiV_Patient_Level_Data_Sharing_Final_28May2026.pdf
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
Data sharing details ↗ · www.viiv-studyregister.com
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Feb 2027, 3 months later.
Of 74 industry-sponsored phase 1 interventional studies under HIV Infections, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 18. This study's planned 3 months is below that.
Counting every sponsor, half of 165 studies reached it within 19 months; a quarter within 7 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dezecapavir