HIV InfectionsPhase 1/2CABNATENCT07275606
A Study to Investigate Cabotegravir for Neonates Exposed to HIV-1
A Phase 1/2 study testing Oral CAB and IM CAB LA in people with HIV Infections, run by ViiV Healthcare at 1 site in South Africa.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of cabotegravir in neonates exposed to human immunodeficiency virus (HIV)-1. Read more about this study
- Who is it for?
- Ages Up to 10 daysHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Oral CAB and IM CAB LA
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Africa
- Study dates
- 15 Apr 2026to 10 Oct 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 Up to 10 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- At least 37 weeks gestation at delivery.
- <=10 days of life.
- Birth weight at least 2 kg.
- At Entry, neonate has initiated standard of care Antiretroviral drug (ARV) prophylaxis.
- At Entry, neonate is generally healthy as determined by the site Investigator based on review of all available medical history information and physical examination findings.
- Mother is on a Dolutegravir (DTG) based regimen for a minimum of 4 weeks prior to delivery, regardless of maternal viral load.
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- Mother is currently breastfeeding or plans to breastfeed infant.
- Mother is of legal age or circumstance to provide independent informed consent and is willing and able to provide documented informed consent for her and her infant's participation in this study.
- Mother has confirmed HIV-1 infection based on positive test results from 2 samples collected from 2 separate blood samples. Test results may be obtained from medical records or from testing performed during the study Screening period.
Who cannot join
- Medical conditions
- Severe congenital malformation or other medical condition not compatible with life or that would interfere with study participation or interpretation, as judged by examining clinician.
- Known maternal-fetal blood group incompatibility which can result in hemolytic disease of the newborn.
- Known family history of G6PD deficiency.
- Prior/Concomitant therapy
- Mother who has previously received, is receiving, or will be receiving CAB post-partum.
Show all 27Show fewer
- Neonate or breastfeeding mother is receiving any disallowed medication.
- Prior/Concurrent clinical study participation
- Neonate has exposure to other investigational drugs that might interfere with study intervention metabolism.
- Diagnostic assessments
- Mother has known Integrase strand transfer inhibitor (InSTI) resistance.
- At Entry, neonate with a confirmed, documented positive HIV Nucleic acid amplification test (NAAT) test result.
- At Screening, neonate has any of the following laboratory test results:
- Alanine transaminase or Aspartate aminotransferase of more than 2.5 x Upper limit of normal (ULN).
- Total bilirubin in range for phototherapy at Entry.
- Hemoglobin <13.0 g/dL.
- Decreased white blood cells Grade 3 or above.
- Platelets <50 000 cells/mm3
- Creatinine value more than 1.3 the ULN for postnatal age as defined in Division of AIDS (DAIDS)
- Albumin Grade 3 or higher.
- Direct bilirubin Grade 3 and above.
- Any other Grade ≥3 event on DAIDS toxicity table
- Neonates with prior exchange transfusion. Other exclusion criteria
- Mother or neonate has a condition that, in the site Investigator or designee's opinion, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
- Neonate is receiving DTG as part of HIV prophylactic regimen. Liver safety exclusion criteria
- Known maternal hepatitis B infection. Cardiac safety exclusion criteria
- At screening, QT interval corrected using Fridericia's formula >450 msec.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa1 site, 1 recruiting
- Recruiting
GSK Investigational Site
Parow Valley, 7505
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: A Phase 1/2 Study of the Safety, Tolerability, and Pharmacokinetics of Cabotegravir in Neonates Exposed to HIV-1
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of cabotegravir in neonates exposed to human immunodeficiency virus (HIV)-1.
- Conditions
- HIV Infections
- Being tested
- Oral CAB, IM CAB LA
- Keywords
- Cabotegravir, Neonate, HIV, Safety, Tolerability, Pharmacokinetics
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral CABDrug
Also called Cabotegravir
CAB administered once orally on study Day 1 to the Stage 1: Single Oral Dose CAB (Cohort 1) and multiple times to the Stage 1: Multiple Oral Dose CAB (Cohort 2) group. Dose and dosing frequency for Cohort 2 to be determined based on emerging data from Cohort 1.
IM CAB LADrug
Also called Cabotegravir long-acting
CAB LA administered once intramuscularly on study Day 1 to the Stage 2: Single IM Dose CAB LA (Cohort 3) group and multiple times to the Stage 2: Multiple IM Dose CAB LA (Cohort 4) group, into the in the anterolateral thigh muscle of participants. Dose for Cohort 3 to be determined based on emerging data from Cohort 2. Dose and dosing frequency for Cohort 4 to be determined based on emerging data from Cohort 3.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1: Single Oral Dose CAB (Cohort 1) group | Experimental | Participants receive a single dose of oral CAB suspension on study Day 1. Receives: Drug: Oral CAB |
| Stage 1: Multiple Oral Dose CAB (Cohort 2) group | Experimental | Participants receive repeat doses of oral CAB suspension starting on study Day 1. Dose and dosing frequency to be determined based on data from Cohort 1. Receives: Drug: Oral CAB |
| Stage 2: Single IM Dose CAB LA (Cohort 3) group | Experimental | Participants receive a single IM dose of CAB LA on study Day 1. Dose to be determined based on data from Cohort 2. Receives: Drug: IM CAB LA |
| Stage 2: Multiple IM Dose CAB LA (Cohort 4) group | Experimental | Participants receive repeat IM doses of CAB LA starting on study Day 1. Dose and dosing frequency to be determined based on data from Cohort 3. Receives: Drug: IM CAB LA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of CAB in participants from Stage 1: Single Oral Dose CAB (Cohort 1) group
Blood samples are collected at specific time points for PK analysis to determine Cmax.
Measured: At study Days 1, 3, 8, 15 and 22
Maximum observed plasma concentration (Cmax) of CAB LA in participants from Stage 2: Single IM Dose CAB LA (Cohort 3) group
Blood samples are collected at specific time points for PK analysis to determine Cmax.
Measured: At study Days 1, 3, 9,16, 28 and 42
Last observed plasma concentration (Clast) of CAB in participants from Stage 1: Single Oral Dose CAB (Cohort 1) group
Blood samples are collected at specific time points for PK analysis to determine Clast.
Measured: At study Days 1, 3, 8, 15 and 22
Last observed plasma concentration (Clast) of CAB LA in participants from Stage 2: Single IM Dose CAB LA (Cohort 3) group
Blood samples are collected at specific time points for PK analysis to determine Clast.
Measured: At study Days 1, 3, 9, 16, 28 and 42
Area under the curve time 0 to the last time point (AUC0-t) of CAB in participants from Stage 1: Single Oral Dose CAB (Cohort 1) group
Blood samples are collected at specific time points for PK analysis to determine AUC0-t.
Measured: At study Days 1, 3, 8, 15 and 22
Area under the curve time 0 to the last time point (AUC0-t) of CAB LA in participants from Stage 2: Single IM Dose CAB LA (Cohort 3) group
Blood samples are collected at specific time points for PK analysis to determine AUC0-t.
Measured: At study Days 1, 3, 9, 16, 28 and 42
Pre-dose concentrations (C0h) of CAB in participants from Stage 1: Multiple Oral Dose CAB (Cohort 2) group
Blood samples are collected at specific time points for PK analysis to determine C0h.
Measured: At Study Days 1, 3, 7, 14, 28, 35, 42 and 49
Pre-dose concentrations (C0h) of CAB LA in participants from Stage 2: Multiple IM Dose CAB LA (Cohort 4) group
Blood samples are collected at specific time points for PK analysis to determine C0h.
Measured: At Study Days 1, 3, 7, 21, 28, 42, 56, 70, 84, 98, 112, 140 and 168
Post-dose concentrations of CAB in participants from Stage 1: Multiple Oral Dose CAB (Cohort 2) group
Blood samples are collected at specific time points for PK analysis to determine post-dose concentrations.
Measured: At Study Days 1, 3, 7, 14, 21, 28, 35, 42 and 49
Post-dose concentrations of CAB LA in participants from Stage 2: Multiple IM Dose CAB LA (Cohort 4) group
Blood samples are collected at specific time points for PK analysis to determine post-dose concentrations.
Measured: At Study Days 1, 3, 7, 14, 21, 28, 35, 42, 56, 70, 84, 98, 112, 140 and 168
Number of participants with drug-related adverse event (AEs) by severity
A drug-related AE is any untoward medical occurrence in a clinical study participant considered related to the study intervention. The severity of events is graded using the DAIDS grading scale, where grades are defined based on numeric criteria as follows: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life-threatening. A higher grade indicates greater severity.
Measured: From Day 1 up to 2-months post last dose administration (last dose administered at Day 1 to the single dose groups, at Month 1 to Stage 1: Multiple Oral Dose CAB (Cohort 2) group and at Month 6 to Stage 2: Multiple IM Dose CAB LA (Cohort 4) group)
Number of participants with serious AEs (SAEs) by severity
An SAE is defined as any untoward medical occurrence that is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in death.
The severity of events is graded using the DAIDS grading scale, where grades are defined based on numeric criteria as follows: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life-threatening. A higher grade indicates greater severity.
Measured: From Day 1 up to 2-months post last dose administration (last dose administered at Day 1 to the single dose groups, at Month 1 to Stage 1: Multiple Oral Dose CAB (Cohort 2) group and at Month 6 to Stage 2: Multiple IM Dose CAB LA (Cohort 4) group)
Number of participants with injection site reactions (ISRs) by severity
An ISR is defined as an adverse event which is localized at the injection site, typically includes pain, tenderness, erythema, redness, induration, swelling, nodules or pruritus, but may also encompass other reactions. The severity of events is graded using the DAIDS grading scale, where grades are defined based on numeric criteria as follows: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life-threatening. A higher grade indicates greater severity.
Measured: From Day 1 up to 2-months post last dose administration (last dose administered at Day 1 to the single dose groups, at Month 1 to Stage 1: Multiple Oral Dose CAB (Cohort 2) group and at Month 6 to Stage 2: Multiple IM Dose CAB LA (Cohort 4) group)
Number of participants who discontinue the study intervention due to AEs or injection intolerability
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
Measured: From Day 1 up to 2-months post last dose administration (last dose administered at Day 1 to the single dose groups, at Month 1 to Stage 1: Multiple Oral Dose CAB (Cohort 2) group and at Month 6 to Stage 2: Multiple IM Dose CAB LA (Cohort 4) group)
Secondary outcomes (2)
Number of participants developing Grade 3 and higher AEs and SAEs, by severity
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in death. The severity of events is graded using the DAIDS grading scale, where grades are defined based on numeric criteria as follows: Grade 3 = severe and Grade 4 = potentially life-threatening. A higher grade indicates greater severity.
Measured: From Day 1 up to 2-months post last dose administration (last dose administered at Day 1 to the single dose groups, at Month 1 to Stage 1: Multiple Oral Dose CAB (Cohort 2) group and at Month 6 to Stage 2: Multiple IM Dose CAB LA (Cohort 4) group)
Number of participants with Grade 3 and above bilirubin elevation.
The severity of events is graded using the DAIDS grading scale, where grades are defined based on numeric criteria as follows: Grade 3 = severe and Grade 4 = potentially life-threatening. A higher grade indicates greater severity.
Measured: From Day 1 up to 2-months post last dose administration (last dose administered at Day 1 to the single dose groups, at Month 1 to Stage 1: Multiple Oral Dose CAB (Cohort 2) group and at Month 6 to Stage 2: Multiple IM Dose CAB LA (Cohort 4) group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start15 Apr 2026
- Primary completion10 Oct 2029 (estimated)
- Study completion10 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe 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 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The study will be conducted in a staggered design. There will be 2 stages with 2 cohorts in each. The 1st stage will focus on the oral CAB, the 2nd on the CAB LA injectable. In the 1st cohort at each stage, a single dose will be given. In the 2nd cohort of each stage, there will be a multi-dose regimen. Dose review decisions will be based upon safety, tolerability and pharmacokinetic data from each cohort.
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275606
- Sponsor's protocol ID
- 223560
- Acronym
- CABNATE
- Status last verified
- May 2026
- First submitted
- 27 Nov 2025
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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\_25Sep2023.pdf.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of the Safety, Tolerability, and Pharmacokinetics of Cabotegravir in Neonates Exposed to HIV-1
- ClinicalTrials.gov ID
- NCT07275606
- Acronym / sponsor ID
- CABNATE / 223560
- Conditions
- HIV Infections
- Keywords
- Cabotegravir, Neonate, HIV, Safety, Tolerability, Pharmacokinetics
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 10 Oct 2029 (estimated)
- Study completion
- 10 Oct 2029 (estimated)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of cabotegravir in neonates exposed to human immunodeficiency virus (HIV)-1.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The study will be conducted in a staggered design. There will be 2 stages with 2 cohorts in each. The 1st stage will focus on the oral CAB, the 2nd on the CAB LA injectable. In the 1st cohort at each stage, a single dose will be given. In the 2nd cohort of each stage, there will be a multi-dose regimen. Dose review decisions will be based upon safety, tolerability and pharmacokinetic data from each cohort.
| Arm | Type | Receives |
|---|---|---|
| Stage 1: Single Oral Dose CAB (Cohort 1) group | Experimental | Drug: Oral CABParticipants receive a single dose of oral CAB suspension on study Day 1. |
| Stage 1: Multiple Oral Dose CAB (Cohort 2) group | Experimental | Drug: Oral CABParticipants receive repeat doses of oral CAB suspension starting on study Day 1. Dose and dosing frequency to be determined based on data from Cohort 1. |
| Stage 2: Single IM Dose CAB LA (Cohort 3) group | Experimental | Drug: IM CAB LAParticipants receive a single IM dose of CAB LA on study Day 1. Dose to be determined based on data from Cohort 2. |
| Stage 2: Multiple IM Dose CAB LA (Cohort 4) group | Experimental | Drug: IM CAB LAParticipants receive repeat IM doses of CAB LA starting on study Day 1. Dose and dosing frequency to be determined based on data from Cohort 3. |
Who may qualify
- Ages
- Up to 10 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- At least 37 weeks gestation at delivery.
- <=10 days of life.
- Birth weight at least 2 kg.
- At Entry, neonate has initiated standard of care Antiretroviral drug (ARV) prophylaxis.
- At Entry, neonate is generally healthy as determined by the site Investigator based on review of all available medical history information and physical examination findings.
Key exclusion criteria (27 listed)
- Medical conditions
- Severe congenital malformation or other medical condition not compatible with life or that would interfere with study participation or interpretation, as judged by examining clinician.
- Known maternal-fetal blood group incompatibility which can result in hemolytic disease of the newborn.
- Known family history of G6PD deficiency.
- Prior/Concomitant therapy
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 |
|---|---|---|
| Oral CABAlso: CabotegravirCAB administered once orally on study Day 1 to the Stage 1: Single Oral Dose CAB (Cohort 1) and multiple times to the Stage 1: Multiple Oral Dose CAB (Cohort 2) group. Dose and dosing frequency for Cohort 2 to be determined based on emerging data from Cohort 1. | Drug | Stage 1: Multiple Oral Dose CAB (Cohort 2) group, Stage 1: Single Oral Dose CAB (Cohort 1) group |
| IM CAB LAAlso: Cabotegravir long-actingCAB LA administered once intramuscularly on study Day 1 to the Stage 2: Single IM Dose CAB LA (Cohort 3) group and multiple times to the Stage 2: Multiple IM Dose CAB LA (Cohort 4) group, into the in the anterolateral thigh muscle of participants. Dose for Cohort 3 to be determined based on emerging data from Cohort 2. Dose and dosing frequency for Cohort 4 to be determined based on emerging data from Cohort 3. | Drug | Stage 2: Multiple IM Dose CAB LA (Cohort 4) group, Stage 2: Single IM Dose CAB LA (Cohort 3) group |
Primary outcome
Maximum observed plasma concentration (Cmax) of CAB in participants from Stage 1: Single Oral Dose CAB (Cohort 1) group
Time frame: At study Days 1, 3, 8, 15 and 22
Blood samples are collected at specific time points for PK analysis to determine Cmax.
Maximum observed plasma concentration (Cmax) of CAB LA in participants from Stage 2: Single IM Dose CAB LA (Cohort 3) group
Time frame: At study Days 1, 3, 9,16, 28 and 42
Blood samples are collected at specific time points for PK analysis to determine Cmax.
Last observed plasma concentration (Clast) of CAB in participants from Stage 1: Single Oral Dose CAB (Cohort 1) group
Time frame: At study Days 1, 3, 8, 15 and 22
Blood samples are collected at specific time points for PK analysis to determine Clast.
Last observed plasma concentration (Clast) of CAB LA in participants from Stage 2: Single IM Dose CAB LA (Cohort 3) group
Time frame: At study Days 1, 3, 9, 16, 28 and 42
Blood samples are collected at specific time points for PK analysis to determine Clast.
Area under the curve time 0 to the last time point (AUC0-t) of CAB in participants from Stage 1: Single Oral Dose CAB (Cohort 1) group
Time frame: At study Days 1, 3, 8, 15 and 22
Blood samples are collected at specific time points for PK analysis to determine AUC0-t.
Area under the curve time 0 to the last time point (AUC0-t) of CAB LA in participants from Stage 2: Single IM Dose CAB LA (Cohort 3) group
Time frame: At study Days 1, 3, 9, 16, 28 and 42
Blood samples are collected at specific time points for PK analysis to determine AUC0-t.
Pre-dose concentrations (C0h) of CAB in participants from Stage 1: Multiple Oral Dose CAB (Cohort 2) group
Time frame: At Study Days 1, 3, 7, 14, 28, 35, 42 and 49
Blood samples are collected at specific time points for PK analysis to determine C0h.
Pre-dose concentrations (C0h) of CAB LA in participants from Stage 2: Multiple IM Dose CAB LA (Cohort 4) group
Time frame: At Study Days 1, 3, 7, 21, 28, 42, 56, 70, 84, 98, 112, 140 and 168
Blood samples are collected at specific time points for PK analysis to determine C0h.
Post-dose concentrations of CAB in participants from Stage 1: Multiple Oral Dose CAB (Cohort 2) group
Time frame: At Study Days 1, 3, 7, 14, 21, 28, 35, 42 and 49
Blood samples are collected at specific time points for PK analysis to determine post-dose concentrations.
Post-dose concentrations of CAB LA in participants from Stage 2: Multiple IM Dose CAB LA (Cohort 4) group
Time frame: At Study Days 1, 3, 7, 14, 21, 28, 35, 42, 56, 70, 84, 98, 112, 140 and 168
Blood samples are collected at specific time points for PK analysis to determine post-dose concentrations.
Number of participants with drug-related adverse event (AEs) by severity
Time frame: From Day 1 up to 2-months post last dose administration (last dose administered at Day 1 to the single dose groups, at Month 1 to Stage 1: Multiple Oral Dose CAB (Cohort 2) group and at Month 6 to Stage 2: Multiple IM Dose CAB LA (Cohort 4) group)
A drug-related AE is any untoward medical occurrence in a clinical study participant considered related to the study intervention. The severity of events is graded using the DAIDS grading scale, where grades are defined based on numeric criteria as follows: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life-threatening. A higher grade indicates greater severity.
Number of participants with serious AEs (SAEs) by severity
Time frame: From Day 1 up to 2-months post last dose administration (last dose administered at Day 1 to the single dose groups, at Month 1 to Stage 1: Multiple Oral Dose CAB (Cohort 2) group and at Month 6 to Stage 2: Multiple IM Dose CAB LA (Cohort 4) group)
An SAE is defined as any untoward medical occurrence that is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in death. The severity of events is graded using the DAIDS grading scale, where grades are defined based on numeric criteria as follows: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life-threatening. A higher grade indicates greater severity.
Number of participants with injection site reactions (ISRs) by severity
Time frame: From Day 1 up to 2-months post last dose administration (last dose administered at Day 1 to the single dose groups, at Month 1 to Stage 1: Multiple Oral Dose CAB (Cohort 2) group and at Month 6 to Stage 2: Multiple IM Dose CAB LA (Cohort 4) group)
An ISR is defined as an adverse event which is localized at the injection site, typically includes pain, tenderness, erythema, redness, induration, swelling, nodules or pruritus, but may also encompass other reactions. The severity of events is graded using the DAIDS grading scale, where grades are defined based on numeric criteria as follows: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life-threatening. A higher grade indicates greater severity.
Number of participants who discontinue the study intervention due to AEs or injection intolerability
Time frame: From Day 1 up to 2-months post last dose administration (last dose administered at Day 1 to the single dose groups, at Month 1 to Stage 1: Multiple Oral Dose CAB (Cohort 2) group and at Month 6 to Stage 2: Multiple IM Dose CAB LA (Cohort 4) group)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
2 secondary outcomes
Number of participants developing Grade 3 and higher AEs and SAEs, by severity
Time frame: From Day 1 up to 2-months post last dose administration (last dose administered at Day 1 to the single dose groups, at Month 1 to Stage 1: Multiple Oral Dose CAB (Cohort 2) group and at Month 6 to Stage 2: Multiple IM Dose CAB LA (Cohort 4) group)
Number of participants with Grade 3 and above bilirubin elevation.
Time frame: From Day 1 up to 2-months post last dose administration (last dose administered at Day 1 to the single dose groups, at Month 1 to Stage 1: Multiple Oral Dose CAB (Cohort 2) group and at Month 6 to Stage 2: Multiple IM Dose CAB LA (Cohort 4) group)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: 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_25Sep2023.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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Oral CAB and IM CAB LA in people with HIV Infections, run by ViiV Healthcare at 1 site in South Africa.
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 9 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 19 May 2026. 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 South Africa. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed plasma concentration (Cmax) of CAB in participants from Stage 1: Single Oral Dose CAB (Cohort 1) group (time frame: At study Days 1, 3, 8, 15 and 22). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2026.