HivPhase 1/2PETITE-DTGNCT05590325
Pharmacokinetics and Safety of DolutegravIr in Neonate
A Phase 1/2 study testing Dolutegravir in people with Hiv, run by Desmond Tutu TB Centre at 1 site in South Africa.
Trial summary
A Phase I/II, open-label, single arm, two-stage trial to evaluate the single and multi-dose PK and safety of DTG in HIV-exposed neonates on ARV prophylaxis. HIV-exposed term neonates born mothers with HIV on DTG-based antiretroviral therapy with a birth weight ≥2000 g who are on ARV postnatal prophylaxis will be… Read more about this study
- Who is it for?
- Ages 1 day to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Hiv
- What is being tested?
- Dolutegravir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSouth Africa
- Study dates
- 12 Sep 2022to 31 Dec 2024
- Phase
- Phase 1/2
- 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 1 day to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Stage 1: Inclusion Criteria
- HIV-exposed neonate (pending HIV status) born to a woman within HIV on DTG-based ART
- Birth weight of ≥2000 g and on standard of care ARV prophylaxis
- Cohort Specific Inclusion Criteria in Stage 1 must be met at Study Entry:
- Cohort 1A: Infant <14 days of life Cohort 1B: Infant ≤3 days of life
- Stage 2: Inclusion Criteria
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- Low risk* HIV-exposed neonate (pending HIV status) born to a virologically suppressed woman on DTG-based ART
- Neonate born to a woman with a documented plasma HIV-1 RNA result <50 copies/mL in the 4 weeks prior to delivery or between delivery and infant study entry
- Birth weight of ≥2000 g and on standard of care ARV prophylaxis
- Cohort Specific Inclusion Criteria in Stage 2 must be met at Study Entry:
- Cohort 2: Infant <7 days of life
Who cannot join
- • Less than 37 weeks gestational age at birth
- Known blood group incompatibilities which can result in hemolytic disease of the newborn (e.g., Rh-negative mother, presence of antibodies on neonatal red blood cells, etc.)
- Total bilirubin values approaching an exchange transfusion as defined by local guidelines (Section 18.2)
- Haemoglobin value of <13.0 g/dL
- Platelet count of less than 50,000 cells/mm3)
- Decreased total white blood cell count (Grade 3 and above)
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- Creatinine value more than 1.3 the upper limit of normal (ULN) for gestational age and postnatal age (Grade 2 and above)
- AST or ALT of more than 2.5 the ULN (Grade 2 and above)
- Any other current Grade ≥3 event on the DAIDS toxicity table
- Severe congenital abnormalities or critically ill neonates at discretion of the examining clinician
- Receiving medicine(s) that can impact DTG pharmacokinetics (Section 8.7)
- Participation in another clinical trial
- HIV-infected neonates
Trial locations and contacts
1 site in 1 country.
South Africa1 site, 1 recruiting
- Recruiting
Tygerberg Hospital
Cape Town, Western Cape, 7505
Adrie Beker, Prof
About this study
Official title: Open Label, Single Arm, Two-stage Trial to Evaluate the Single and Multi-dose Pharmacokinetics and Safety of the Paediatric Dolutegravir (10 mg, Scored) Dispersible Tablet in HIV-exposed Neonates
A Phase I/II, open-label, single arm, two-stage trial to evaluate the single and multi-dose PK and safety of DTG in HIV-exposed neonates on ARV prophylaxis. HIV-exposed term neonates born mothers with HIV on DTG-based antiretroviral therapy with a birth weight ≥2000 g who are on ARV postnatal prophylaxis will be enrolled.
Read the detailed description
A Phase I/II, open-label, single arm, two-stage trial to evaluate the single and multi-dose PK and safety of DTG in HIV-exposed neonates on ARV prophylaxis. HIV-exposed term neonates born mothers with HIV on DTG-based antiretroviral therapy with a birth weight ≥2000 g who are on ARV postnatal prophylaxis will be enrolled.
Enrolment will be in two stages:
- Stage 1 will assess a single 5 mg dose of the DTG-DT in two sequential cohorts: Cohort 1A (n=8) and Cohort 1B (n=8).
- Stage 2 will assess multiple 5 mg doses of the DTG-DT and DTG-ODF in two parallel cohorts: Cohort 2A (n=20) and Cohort 2B (n=20).
Per national guidelines, all infants receive a birth HIV nucleic acid test (NAT). HIV NAT test results for the infant may or may not be available (HIV pending) at the time of study entry. HIV NAT results are typically available within 72 hours of the blood sample being taken and are checked and acted upon by the hospital HIV PMTCT service, as part of standard of care. If an HIV NAT result comes back positive whilst the neonate is on study, the neonate will not receive any further DTG doses, revert to standard of care antiretroviral therapy (ART), and be followed for safety for the duration of the study.
Primary Objectives:
- To evaluate the pharmacokinetics of dolutegravir (DTG) during the first 28 days of life in HIV-exposed term neonates (born to a mother with HIV) following administration of DTG dispersible tablet (DTG-DT) and DTG oral dispersible film (DTG-ODF)
- To determine the safety of DTG during the first 28 days of life in HIV-exposed term neonates following administration of DTG-DT and DTG-ODF
Secondary Objectives:
- To quantitatively and qualitatively assess the acceptability of DTG-DT and DTG-ODF for the neonate, the caregiver and health workers
Primary endpoints:
- DTG plasma pharmacokinetics parameters: area under the concentration time curve (AUC); maximum plasma concentration (Cmax), apparent clearance (CL/F), and trough concentration (Ctrough)
- Occurrence of the following events: adverse events of Grade 3 or higher; treatment-related adverse events of Grade 3 or higher; any adverse events
Secondary endpoints:
- Acceptability to caregivers and neonates of using DTG-DT will be measured by means of a questionnaire
- Conditions
- Hiv
- Being tested
- Dolutegravir
- Keywords
- HIV exposed, Neonates
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DolutegravirDrug
Single dose of the DTG-DT in two sequential cohorts and multiple-doses of the DTG-DT or DTG-ODF in a two cohorts.
Qualitative Acceptability will be collected from mothers and health workers in structured discussion guides.
| Study group | Role | What they receive |
|---|---|---|
| single arm, two-stage | Experimental | Participants will be enrolled in two stages:
* Stage 1 will assess a single dose of the DTG-DT in two sequential cohorts: Cohort 1A (n=8) and Cohort 1B (n=8).
* Stage 2 will assess multiple-doses of the DTG-DT and the DTG-ODF in a single cohort: Cohort 2A (n=20) DTG-DT and Cohort 2B (n=20) DTG-ODF Receives: Drug: Dolutegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
In Cohort 1, PK analysis will be performed to calculate the following parameter: Cmax
Cmax will be taken directly from the observed concentration-time data.
Measured: first 28 days of life
In Cohort 1, PK analysis will be performed to calculate the following parameter: Clast,
Clast will be taken directly from the observed concentration-time data.
Measured: first 28 days of life
In Cohort 1, PK analysis will be performed to calculate the following parameter: Tmax
Tmax will be taken directly from the observed concentration-time data.
Measured: first 28 days of life
In Cohort 1, PK analysis will be performed to calculate the following parameter: C24
C24 will be taken directly from the observed concentration-time data.
Measured: first 28 days of life
In Cohort 1, PK analysis will be performed to calculate the following parameter: AUC0-24
AUC0-all will be determined using the linear-up log-down trapezoidal method. Total body clearance for extravascular administration will be calculated using Dose/ AUC0-infinity. Median (range), means (standard deviations), and geometric means with 95%CI for each PK parameter will be calculated separately for Cohorts 1A and 1B, as well as for Cohort 1A/1B together.
Measured: first 28 days of life
In Cohort 1, PK analysis will be performed to calculate the following parameter: AUC0-infinity
AUC0-infinity will be determined using the linear-up log-down trapezoidal method. Total body clearance for extravascular administration will be calculated using Dose/ AUC0-infinity. Median (range), means (standard deviations), and geometric means with 95%CI for each PK parameter will be calculated separately for Cohorts 1A and 1B, as well as for Cohort 1A/1B together.
Measured: first 28 days of life
In Cohort 1, PK analysis will be performed to calculate the following parameter: Ratio AUC0-24 / AUC0-infinity
Ratio AUC0-24 / AUC0-infinity will be determined using the linear-up log-down trapezoidal method. Total body clearance for extravascular administration will be calculated using Dose/ AUC0-infinity. Median (range), means (standard deviations), and geometric means with 95%CI for each PK parameter will be calculated separately for Cohorts 1A and 1B, as well as for Cohort 1A/1B together.concentration-time data.
Measured: first 28 days of life
Reporting adverse events of Grade 3 or higher; treatment-related adverse events of Grade 3 or higher; any adverse events neonates following administration of DTG dispersible tablet
Using the DAIDS toxicity table and protocol specific safety criteria
Measured: first 28 days of life
In Cohorts 2A and 2B, both non-compartmental and population PK analyses will be performed using the following parameter: Cmax
Population means and variances of Cmax for DTG will be estimated using nonlinear mixed-effects regression models. Subject covariates will be assessed to explain sources of inter-subject PK variability.
Measured: first 28 days of life
In Cohorts 2A and 2B, both non-compartmental and population PK analyses will be performed using the following parameter: AUC0-tau
Population means and variances of AUC0-tau for DTG will be estimated using nonlinear mixed-effects regression models. Subject covariates will be assessed to explain sources of inter-subject PK variability. Changes in DTG drug exposures in neonates following multi-doses of DTG-DT and DTG-ODF during the first 28 days of life will be estimated using the final model.
Measured: first 28 days of life
In Cohorts 2A and 2B, both non-compartmental and population PK analyses will be performed using the following parameter: CTau
Population means and variances of CTau for DTG will be estimated using nonlinear mixed-effects regression models. Subject covariates will be assessed to explain sources of inter-subject PK variability. Changes in DTG trough concentrations in neonates following multi-doses of DTG-DT and DTG-ODF during the first 28 days of life will be estimated using the final model.
Measured: first 28 days of life
In Cohorts 2A and 2B, both non-compartmental and population PK analyses will be performed using the following parameter: Tmax
Population means and variances of Tmax for DTG will be estimated using nonlinear mixed-effects regression models. Subject covariates will be assessed to explain sources of inter-subject PK variability.
Measured: first 28 days of life
Secondary outcomes (2)
Acceptability to caregivers and neonates of using DTG-DT will be measured by means of a questionnaire
key characteristics: Palatability, Swallowability, the device used to administer the dose, The complexity for the caregiver to prepare the dose correctly, Required dose, Need for a vehicle, Dosing frequency and duration of treatment, Selected administration devices, Primary container closure system, Actual mode of administration that reflects understanding of user instructions and feasibility of following them,
Acceptability will be recorded by focusing on:
Attitude of the child when presented with the formulation: facial expression, crying or smiling, reaction to drug intake, fighting drug intake, spitting out the suspension, Swallowability, i.e., ability to take the full dose, The way the caregiver prepares the dose
Measured: first 28 days of life
Qualitative acceptability data from mothers and health workers
Data will be collected using a semi-structured discussion guide
Measured: first 28 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start12 Sep 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Phase I/II, open-label, single arm, two-stage pharmacokinetic and safety study
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Desmond Tutu TB Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Chiang Mai University, UNITAID, University of Stellenbosch
- Responsible party
- Sponsor
- Investigators
- Adrie Bekker, Prof, Principal investigator, University of Stellenbosch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590325
- Sponsor's protocol ID
- 2019-36-SUN-MDR
- Acronym
- PETITE-DTG
- Status last verified
- Sep 2023
- First submitted
- 6 Sep 2022
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bekker A, Salvadori N, Rabie H, du Toit S, Than-In-At K, Groenewald M, Barnabas S, Ganger L, Luangcharoenkul T, Pingkarawat S, Capparelli EV, Owen A, Cressey R, Fry S, Le Roux G, Tawon Y, Kaewmalee J, Phitak T, Lallemant M, Cotton MF, Cressey TR. Safety and pharmacokinetics of dolutegravir dispersible tablets and oral films in term neonates exposed to HIV in South Africa (PETITE-DTG study): an open-label, randomised, phase 1/2 trial. Lancet HIV. 2025 Nov;12(11):e753-e762. doi: 10.1016/S2352-3018(25)00239-5. Epub 2025 Oct 8.
PubMed 41075812Cressey TR, Salvadori N, Rabie H, du Toit S, Than-In-At K, Groenewald M, Capparelli E, Owen A, Cressey R, Lallemant M, Cotton MF, Bekker A. Single Doses of Pediatric Dolutegravir Dispersible Tablets in Neonates Support Multidosing: PETITE-Dolutegravir Study. J Acquir Immune Defic Syndr. 2025 Jun 1;99(2):195-201. doi: 10.1097/QAI.0000000000003652.
PubMed 39972540
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Single Arm, Two-stage Trial to Evaluate the Single and Multi-dose Pharmacokinetics and Safety of the Paediatric Dolutegravir (10 mg, Scored) Dispersible Tablet in HIV-exposed Neonates
- ClinicalTrials.gov ID
- NCT05590325
- Acronym / sponsor ID
- PETITE-DTG / 2019-36-SUN-MDR
- Conditions
- Hiv
- Keywords
- HIV exposed, Neonates
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Desmond Tutu TB CentreUniversity, hospital or other
- Collaborators
- Chiang Mai University, UNITAID, University of Stellenbosch
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Oct 2022 (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.
A Phase I/II, open-label, single arm, two-stage trial to evaluate the single and multi-dose PK and safety of DTG in HIV-exposed neonates on ARV prophylaxis. HIV-exposed term neonates born mothers with HIV on DTG-based antiretroviral therapy with a birth weight ≥2000 g who are on ARV postnatal prophylaxis will be enrolled.
Detailed description
A Phase I/II, open-label, single arm, two-stage trial to evaluate the single and multi-dose PK and safety of DTG in HIV-exposed neonates on ARV prophylaxis. HIV-exposed term neonates born mothers with HIV on DTG-based antiretroviral therapy with a birth weight ≥2000 g who are on ARV postnatal prophylaxis will be enrolled.
Enrolment will be in two stages:
- Stage 1 will assess a single 5 mg dose of the DTG-DT in two sequential cohorts: Cohort 1A (n=8) and Cohort 1B (n=8).
- Stage 2 will assess multiple 5 mg doses of the DTG-DT and DTG-ODF in two parallel cohorts: Cohort 2A (n=20) and Cohort 2B (n=20).
Per national guidelines, all infants receive a birth HIV nucleic acid test (NAT). HIV NAT test results for the infant may or may not be available (HIV pending) at the time of study entry. HIV NAT results are typically available within 72 hours of the blood sample being taken and are checked and acted upon by the hospital HIV PMTCT service, as part of standard of care. If an HIV NAT result comes back positive whilst the neonate is on study, the neonate will not receive any further DTG doses, revert to standard of care antiretroviral therapy (ART), and be followed for safety for the duration of the study.
Primary Objectives:
- To evaluate the pharmacokinetics of dolutegravir (DTG) during the first 28 days of life in HIV-exposed term neonates (born to a mother with HIV) following administration of DTG dispersible tablet (DTG-DT) and DTG oral dispersible film (DTG-ODF)
- To determine the safety of DTG during the first 28 days of life in HIV-exposed term neonates following administration of DTG-DT and DTG-ODF
Secondary Objectives:
- To quantitatively and qualitatively assess the acceptability of DTG-DT and DTG-ODF for the neonate, the caregiver and health workers
Primary endpoints:
- DTG plasma pharmacokinetics parameters: area under the concentration time curve (AUC); maximum plasma concentration (Cmax), apparent clearance (CL/F), and trough concentration (Ctrough)
- Occurrence of the following events: adverse events of Grade 3 or higher; treatment-related adverse events of Grade 3 or higher; any adverse events
Secondary endpoints:
- Acceptability to caregivers and neonates of using DTG-DT will be measured by means of a questionnaire
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase I/II, open-label, single arm, two-stage pharmacokinetic and safety study
| Arm | Type | Receives |
|---|---|---|
| single arm, two-stage | Experimental | Drug: DolutegravirParticipants will be enrolled in two stages: * Stage 1 will assess a single dose of the DTG-DT in two sequential cohorts: Cohort 1A (n=8) and Cohort 1B (n=8). * Stage 2 will assess multiple-doses of the DTG-DT and the DTG-ODF in a single cohort: Cohort 2A (n=20) DTG-DT and Cohort 2B (n=20) DTG-ODF |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Stage 1: Inclusion Criteria
- Cohort 1A: Infant <14 days of life Cohort 1B: Infant ≤3 days of life
- Stage 2: Inclusion Criteria
- Low risk* HIV-exposed neonate (pending HIV status) born to a virologically suppressed woman on DTG-based ART
- Neonate born to a woman with a documented plasma HIV-1 RNA result <50 copies/mL in the 4 weeks prior to delivery or between delivery and infant study entry
Key exclusion criteria (13 listed)
- • Less than 37 weeks gestational age at birth
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 |
|---|---|---|
| DolutegravirSingle dose of the DTG-DT in two sequential cohorts and multiple-doses of the DTG-DT or DTG-ODF in a two cohorts. Qualitative Acceptability will be collected from mothers and health workers in structured discussion guides. | Drug | single arm, two-stage |
Primary outcome
In Cohort 1, PK analysis will be performed to calculate the following parameter: Cmax
Time frame: first 28 days of life
Cmax will be taken directly from the observed concentration-time data.
In Cohort 1, PK analysis will be performed to calculate the following parameter: Clast,
Time frame: first 28 days of life
Clast will be taken directly from the observed concentration-time data.
In Cohort 1, PK analysis will be performed to calculate the following parameter: Tmax
Time frame: first 28 days of life
Tmax will be taken directly from the observed concentration-time data.
In Cohort 1, PK analysis will be performed to calculate the following parameter: C24
Time frame: first 28 days of life
C24 will be taken directly from the observed concentration-time data.
In Cohort 1, PK analysis will be performed to calculate the following parameter: AUC0-24
Time frame: first 28 days of life
AUC0-all will be determined using the linear-up log-down trapezoidal method. Total body clearance for extravascular administration will be calculated using Dose/ AUC0-infinity. Median (range), means (standard deviations), and geometric means with 95%CI for each PK parameter will be calculated separately for Cohorts 1A and 1B, as well as for Cohort 1A/1B together.
In Cohort 1, PK analysis will be performed to calculate the following parameter: AUC0-infinity
Time frame: first 28 days of life
AUC0-infinity will be determined using the linear-up log-down trapezoidal method. Total body clearance for extravascular administration will be calculated using Dose/ AUC0-infinity. Median (range), means (standard deviations), and geometric means with 95%CI for each PK parameter will be calculated separately for Cohorts 1A and 1B, as well as for Cohort 1A/1B together.
In Cohort 1, PK analysis will be performed to calculate the following parameter: Ratio AUC0-24 / AUC0-infinity
Time frame: first 28 days of life
Ratio AUC0-24 / AUC0-infinity will be determined using the linear-up log-down trapezoidal method. Total body clearance for extravascular administration will be calculated using Dose/ AUC0-infinity. Median (range), means (standard deviations), and geometric means with 95%CI for each PK parameter will be calculated separately for Cohorts 1A and 1B, as well as for Cohort 1A/1B together.concentration-time data.
Reporting adverse events of Grade 3 or higher; treatment-related adverse events of Grade 3 or higher; any adverse events neonates following administration of DTG dispersible tablet
Time frame: first 28 days of life
Using the DAIDS toxicity table and protocol specific safety criteria
In Cohorts 2A and 2B, both non-compartmental and population PK analyses will be performed using the following parameter: Cmax
Time frame: first 28 days of life
Population means and variances of Cmax for DTG will be estimated using nonlinear mixed-effects regression models. Subject covariates will be assessed to explain sources of inter-subject PK variability.
In Cohorts 2A and 2B, both non-compartmental and population PK analyses will be performed using the following parameter: AUC0-tau
Time frame: first 28 days of life
Population means and variances of AUC0-tau for DTG will be estimated using nonlinear mixed-effects regression models. Subject covariates will be assessed to explain sources of inter-subject PK variability. Changes in DTG drug exposures in neonates following multi-doses of DTG-DT and DTG-ODF during the first 28 days of life will be estimated using the final model.
In Cohorts 2A and 2B, both non-compartmental and population PK analyses will be performed using the following parameter: CTau
Time frame: first 28 days of life
Population means and variances of CTau for DTG will be estimated using nonlinear mixed-effects regression models. Subject covariates will be assessed to explain sources of inter-subject PK variability. Changes in DTG trough concentrations in neonates following multi-doses of DTG-DT and DTG-ODF during the first 28 days of life will be estimated using the final model.
In Cohorts 2A and 2B, both non-compartmental and population PK analyses will be performed using the following parameter: Tmax
Time frame: first 28 days of life
Population means and variances of Tmax for DTG will be estimated using nonlinear mixed-effects regression models. Subject covariates will be assessed to explain sources of inter-subject PK variability.
2 secondary outcomes
Acceptability to caregivers and neonates of using DTG-DT will be measured by means of a questionnaire
Time frame: first 28 days of life
Qualitative acceptability data from mothers and health workers
Time frame: first 28 days of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Derived from this study: PubMed 41075812Bekker A, Salvadori N, Rabie H, du Toit S, Than-In-At K, Groenewald M, Barnabas S, Ganger L, Luangcharoenkul T, Pingkarawat S, Capparelli EV, Owen A, Cressey R, Fry S, Le Roux G, Tawon Y, Kaewmalee J, Phitak T, Lallemant M, Cotton MF, Cressey TR. Safety and pharmacokinetics of dolutegravir dispersible tablets and oral films in term neonates exposed to HIV in South Africa (PETITE-DTG study): an open-label, randomised, phase 1/2 trial. Lancet HIV. 2025 Nov;12(11):e753-e762. doi: 10.1016/S2352-3018(25)00239-5. Epub 2025 Oct 8.
- Derived from this study: PubMed 39972540Cressey TR, Salvadori N, Rabie H, du Toit S, Than-In-At K, Groenewald M, Capparelli E, Owen A, Cressey R, Lallemant M, Cotton MF, Bekker A. Single Doses of Pediatric Dolutegravir Dispersible Tablets in Neonates Support Multidosing: PETITE-Dolutegravir Study. J Acquir Immune Defic Syndr. 2025 Jun 1;99(2):195-201. doi: 10.1097/QAI.0000000000003652.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Adrie Bekker, Prof principal investigator
University of Stellenbosch
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 Dolutegravir in people with Hiv, run by Desmond Tutu TB Centre 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 11 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 18 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adrie Bekker, Prof (+27 (0)219389198, adrie@sun.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In Cohort 1, PK analysis will be performed to calculate the following parameter: Cmax (time frame: first 28 days of life). The study lists 12 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 NCT05590325, which also lists 2 linked publications.
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 18 Dec 2023; AzTrials last refreshed its copy on 8 Nov 2026.