HIVPhase 1/2LOLIPOPNCT03836833

Lopinavir/r/ Lamivudine/ Abacavir as an Easy to Use Paediatric Formulation

A Phase 1/2 study testing ABC/3TC/LPV/r granules (30/15/40/10 mgs) and LPV/r Pellets (40/10mgs) plus ABC/3TC (60/30mgs) in people with HIV, run by Drugs for Neglected Diseases at 3 sites in Uganda.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

A phase I/II, open label, randomized crossover pharmacokinetic, safety and acceptability study of the Abacavir/Lamivudine/ Lopinavir/Ritonavir (30/15/ 40/10mg ;4-in-1) Fixed-Dose Combination vs. Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg tablets) in HIV infected Children. Read more about this study

Who is it for?: Ages 4 weeks and older
Conditions the study is for: HIV
What is being tested?: ABC/3TC/LPV/r granules (30/15/40/10 mgs) and LPV/r Pellets (40/10mgs) plus ABC/3TC (60/30mgs)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 3 sitesUganda
Study dates: 4 Jun 2019to Dec 2019
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 4 weeks and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Children > 4 weeks old and weighing ≥3 and <25 kg at the time of enrolment
Past or current documentation of a confirmed diagnosis of HIV infection defined as two positive assays from two different samples. The two results may be in any combination of the following:
At any age: HIV-1 DNA PCR positive
Documented past HIV-1 RNA viral load > 1,000 copies/mL plasma
At any age >18 months of age: HIV-1 antibody reactive on two different rapid tests based on national testing algorithm
ARV treatment eligible children with LPV-based treatment indication* as defined by country-specific guidelines or the WHO paediatric treatment guidelines and confirmed by the investigator

Show all 11Show fewer

HIV RNA viral load <1000 copies/mL (suppressed) at the screening visit*
Inability to swallow LPV/r tablets
Parent or guardian able and willing to provide written informed consent.
For lowest weight band (≥3 and ≤ 5.9kgs) ONLY: under treatment for at least 3 weeks but not more than 12 weeks.
Does not apply to the youngest children (≥3 and ≤ 5.9kgs)

Who cannot join

Planned or concurrent use of NNRTIs, integrase inhibitors, entry inhibitors, or Protease Inhibitors (PIs) other than LPV/r.
Treatment failure with proven resistances to PIs.
Contraindication to use of PIs
Clinical condition requiring the use of a prohibited medication (see section 7.6) in association with LPV/r, ABC/3TC (Refer to section 7.2- 7.3 of the IB)
Pulmonary Tuberculosis and any clinically significant disease or finding during screening that, in the investigator's opinion, would compromise participation in this study.
Treatment with experimental drugs (except for LPV/r Pellets) for any indication within 30 days prior to study entry
Anticipated transfer of care to a non-participating health facility during the study period

Trial locations and contacts

3 sites in 1 country.

Isabelle Andrieux-Meyer, MD contact

+41 22 906 92 68

iandrieux-meyer@dndi.org

Uganda3 sites, 3 recruiting

Baylor College of Medicine Children's Foundation Uganda
Kampala
Prof. Adeodata Kekitiinwa, MBChM, MMeD, +256772462686, akekitiinwa@baylor-uganda.org
Recruiting
Joint Clinical research Centre
Kampala
Victor Musiime, MBChB,PhD, +256 417 723000, vmusiime@jcrc.org.ug
Recruiting
Epicentre Mbarara Research Centre
Mbarara
Prof. Juliet Mwanga, MBChB, MMED, +256 793328748, juliet.mwanga@epicentre.msf.org
Recruiting

Other trials in Uganda

About this study

Official title: Pharmacokinetic, Safety and Acceptability Study of the Abacavir/Lamivudine/Lopinavir/Ritonavir/-30/15/ 40/10mg vs. Lopinavir/Ritonavir 40/10mg Pellets Plus Dual Abacavir/Lamivudine-60/30mg Tablets in HIV Infected Children

The study is intended to support the adoption of the 4-in-1 by healthcare providers and will provide data that may support its registration in certain countries. The study will be carried out in HIV-infected children in Uganda weighing 3 to 25 kg (inclusive) and unable to swallow tablets and will provide supportive clinical data on the pharmacokinetics, safety, tolerability and acceptability of the 4-in-1.

Read the detailed description

The primary objective is to estimate the population average exposure to LPV, ABC and 3TC provided by the 4-in-1 formulation in HIV-infected children dosed per WHO weight bands.

The secondary objectives:

To determine the proportion of children overall, and within each weight band, with a lopinavir C12 <1.0 mg/L while receiving the 4-in-1 formulation
To evaluate and compare the safety and tolerability of the 4-in-1 formulation versus a reference treatment regimen.
To compare the bioavailability of LPV, ABC and 3TC in the 4-in-1 formulation versus a reference treatment regimen.
To assess post exposure CD4 and viral load
To assess the factors that contribute to acceptability of the new 4-in-1 formulation.

Conditions: HIV
Being tested: ABC/3TC/LPV/r granules (30/15/40/10 mgs), LPV/r Pellets (40/10mgs) plus ABC/3TC (60/30mgs)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ABC/3TC/LPV/r granules (30/15/40/10 mgs)Drug
Also called 4in1 Granules
This is a fixed dose combination. Each capsule contains Lopinavir (40mg), Ritonavir (10mg), Abacavir (30mg) and Lamivudine (15mg) in granules formulation.
Dosage according to patient's weight:
Between 3 and 5.9kg: 2 capsules twice a day Between 6 and 9.9kg: 3 capsules twice a day Between 10 and 13.9kg: 4 capsules twice a day Between 14 and 19.9kg: 5 capsules twice a day Between 20 and 24.9kg: 6 capsules twice a day
LPV/r Pellets (40/10mgs) plus ABC/3TC (60/30mgs)Drug
Also called L PV/r Pellets Plus ABC/3TC tablets
Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg dispersible tablets)
Dosage according to patient's weight:
LPV/r Pellets:
Between 3 and 5.9kg: 2 capsules twice a day Between 6 and 9.9kg: 3 capsules twice a day Between 10 and 13.9kg: 4 capsules twice a day Between 14 and 19.9kg: 5 capsules twice a day Between 20 and 24.9kg: 6 capsules twice a day
ABC/3TC:
Between 3 and 5.9kg: 1 tablet twice a day Between 6 and 9.9kg: 1.5 tablets twice a day Between 10 and 13.9kg: 2 tablets twice a day Between 14 and 19.9kg: 2.5 tablets twice a day Between 20 and 24.9kg: 3 tablets twice a day

Study groups in NCT03836833
Study group	Role	What they receive
4in1 granules	Experimental	Abacavir/Lamivudine/ Lopinavir/Ritonavir (30/15/ 40/10mg ;4-in-1) Fixed-Dose Combination in granules formulation administered twice daily for at least 3 weeks, Followed by Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg dispersible tablets) administered twice daily for at least 3 weeks. Receives: Drug: ABC/3TC/LPV/r granules (30/15/40/10 mgs); Drug: LPV/r Pellets (40/10mgs) plus ABC/3TC (60/30mgs)
LPV/r Pellets Plus ABC/3TC	Experimental	Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg dispersible tablets) administered twice daily for at least 3 weeks. Followed by Abacavir/Lamivudine/ Lopinavir/Ritonavir (30/15/ 40/10mg ;4-in-1) Fixed-Dose Combination in granules formulation administered twice daily for at least 3 weeks Receives: Drug: ABC/3TC/LPV/r granules (30/15/40/10 mgs); Drug: LPV/r Pellets (40/10mgs) plus ABC/3TC (60/30mgs)

What is being measured

The primary outcome is the main question the study is designed to answer.

0 -12 hours Area under the curve plasma concentration versus time for LPV, ABC and 3TC in the 4-in- formulation
0 -12 hours Area under the curve plasma concentration versus time for LPV, ABC and 3TC in the 4-in- formulation
Measured: 0-12 hours

Secondary outcomes (14)

Plasma concentration at 12 hours for LPV in the 4in1 formulation
Plasma concentration at 12 hours for LPV in the 4in1 formulation
Measured: 12 hours
Peak plasma concentration (Cmax) of LPV, ABC and 3TC with the 4-in-1 formulation.
Plasma concentration maximum of LPV, ABC and 3TC with the 4-in-1 formulation.
Measured: 3-5 weeks
Concentration time maximum for LPV, ABC and 3TC with the 4-in-1 formulation.
Concentration time maximum for LPV, ABC and 3TC with the 4-in-1 formulation.
Measured: 3-5 weeks
Clearance function for LPV, ABC and 3TC with the 4-in-1 formulation.
Clearance function for LPV, ABC and 3TC with the 4-in-1 formulation.
Measured: 3-5 weeks
Geometric mean ratio (GMR) of steady state LPV, ABC and 3TC versus time (0-12) in the 4-in-1 formulation versus the reference treatment regimen
Geometric mean ratio (GMR) of steady state LPV, ABC and 3TC versus time (0-12) in the 4-in-1 formulation versus the reference treatment regimen.
Measured: 0 - 12 hours
Area under curve plasma concentration versus time (0-12) in the 4-in-1 formulation versus the reference treatment regimen.
Area under curve plasma concentration versus time (0-12) in the 4-in-1 formulation versus the reference treatment regimen.
Measured: 0 - 12 hours
Geometric mean ratio (GMR) of steady state LPV, ABC and 3TC in the 4-in-1 formulation versus the reference treatment regimen.
Geometric mean ratio (GMR) of steady state LPV, ABC and 3TC in the 4-in-1 formulation versus the reference treatment regimen.
Measured: 0 - 12 hours
Peak plasma concentration in the 4-in-1 formulation versus the reference treatment regimen.
Peak plasma concentration in the 4-in-1 formulation versus the reference treatment regimen.
Measured: 3-5 weeks
Safety: A description of the proportion of children experiencing an Adverse event or Serious Adverse event binomial distribution compared between the two formulations.
Safety: A description of the proportion of children experiencing an Adverse event or Serious Adverse event binomial distribution compared between the two formulations.
Measured: 6-8 weeks
Safety: Summary of the number and percent of subjects with documented Grade 3 or higher adverse events; each summary will be conducted overall and by formulation
Safety: Summary of the number and percent of subjects with documented Grade 3 or higher adverse events; each summary will be conducted overall and by formulation
Measured: 6-8 weeks
Proportion of children with viral load <1000 copies/ml
Comparison of proportion of children with viral load less than 1000 copies/ml at baseline and at end of the study.
Measured: 6-8 weeks
Changes in CD4 counts compared to baseline
Changes in CD4 counts compared to baseline
Measured: 6-8 week
Changes in CD4 percentage compared to baseline
Changes in CD4 percentage compared to baseline
Measured: 6-8 weeks
Acceptability: Description of factors that affect acceptability of the 4 in1 formulation
Description of factors that affect acceptability of the 4in1 formulation as reported by the caregivers
Measured: 6-8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jun 2019Dec 2019

First posted11 Feb 2019
Study start4 Jun 2019
Primary completionNov 2019 (estimated)
Study completionDec 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03836833
Sponsor's protocol ID: DNDi-4in1-01-PHIV
Acronym: LOLIPOP
Status last verified: May 2019
First submitted: 13 Dec 2018
Last updated: 7 Jun 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Rotsaert A, Ogara C, Mwanga-Amumpaire J, Kekitiinwa AR, Musiime V, Najjingo E, Kisitu GP, Nazzinda R, Nambi E, Lee J, Diallo M, Kyomuhendo F, Waweru M, Andrieux-Meyer I, Nostlinger C. Acceptability of a new 4-in-1 Abacavir/Lamivudine/Lopinavir/Ritonavir paediatric fixed-dose combination: the caregiver-child dyads' perspective. Ther Adv Infect Dis. 2023 Mar 21;10:20499361231159993. doi: 10.1177/20499361231159993. eCollection 2023 Jan-Dec.
PubMed 36968554

Want to know more?

Isabelle Andrieux-Meyer, MD

+41 22 906 92 68

iandrieux-meyer@dndi.org

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetic, Safety and Acceptability Study of the Abacavir/Lamivudine/Lopinavir/Ritonavir/-30/15/ 40/10mg vs. Lopinavir/Ritonavir 40/10mg Pellets Plus Dual Abacavir/Lamivudine-60/30mg Tablets in HIV Infected Children
ClinicalTrials.gov ID: NCT03836833
Acronym / sponsor ID: LOLIPOP / DNDi-4in1-01-PHIV
Conditions: HIV
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 50 participants (estimated)
Lead sponsor: Drugs for Neglected DiseasesUniversity, hospital or other
Collaborators: UNITAID, AMS-PHPT Research Platform (Program for HIV Prevention and Treatment), Joint Clinical Research Centre- Kampala, Baylor College of Medicine Children's Foundation, Epcentre Centre Mbarara Research Centre, Institute of Tropical Medicine, Belgium
Study start: 4 Jun 2019 (actual)
Primary completion: Nov 2019 (estimated)
Study completion: Dec 2019 (estimated)
First posted: 11 Feb 2019 (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.

Detailed description

The primary objective is to estimate the population average exposure to LPV, ABC and 3TC provided by the 4-in-1 formulation in HIV-infected children dosed per WHO weight bands.

The secondary objectives:

To determine the proportion of children overall, and within each weight band, with a lopinavir C12 <1.0 mg/L while receiving the 4-in-1 formulation
To evaluate and compare the safety and tolerability of the 4-in-1 formulation versus a reference treatment regimen.
To compare the bioavailability of LPV, ABC and 3TC in the 4-in-1 formulation versus a reference treatment regimen.
To assess post exposure CD4 and viral load
To assess the factors that contribute to acceptability of the new 4-in-1 formulation.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
4in1 granules	Experimental	Drug: ABC/3TC/LPV/r granules (30/15/40/10 mgs), Drug: LPV/r Pellets (40/10mgs) plus ABC/3TC (60/30mgs)Abacavir/Lamivudine/ Lopinavir/Ritonavir (30/15/ 40/10mg ;4-in-1) Fixed-Dose Combination in granules formulation administered twice daily for at least 3 weeks, Followed by Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg dispersible tablets) administered twice daily for at least 3 weeks.
LPV/r Pellets Plus ABC/3TC	Experimental	Drug: ABC/3TC/LPV/r granules (30/15/40/10 mgs), Drug: LPV/r Pellets (40/10mgs) plus ABC/3TC (60/30mgs)Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg dispersible tablets) administered twice daily for at least 3 weeks. Followed by Abacavir/Lamivudine/ Lopinavir/Ritonavir (30/15/ 40/10mg ;4-in-1) Fixed-Dose Combination in granules formulation administered twice daily for at least 3 weeks

Who may qualify

Ages: 4 weeks and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (11 listed)

Children > 4 weeks old and weighing ≥3 and <25 kg at the time of enrolment
Past or current documentation of a confirmed diagnosis of HIV infection defined as two positive assays from two different samples. The two results may be in any combination of the following:
At any age: HIV-1 DNA PCR positive
Documented past HIV-1 RNA viral load > 1,000 copies/mL plasma
At any age >18 months of age: HIV-1 antibody reactive on two different rapid tests based on national testing algorithm

Key exclusion criteria (7 listed)

Planned or concurrent use of NNRTIs, integrase inhibitors, entry inhibitors, or Protease Inhibitors (PIs) other than LPV/r.
Treatment failure with proven resistances to PIs.
Contraindication to use of PIs
Clinical condition requiring the use of a prohibited medication (see section 7.6) in association with LPV/r, ABC/3TC (Refer to section 7.2- 7.3 of the IB)
Pulmonary Tuberculosis and any clinically significant disease or finding during screening that, in the investigator's opinion, would compromise participation in this study.

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
ABC/3TC/LPV/r granules (30/15/40/10 mgs)Also: 4in1 GranulesThis is a fixed dose combination. Each capsule contains Lopinavir (40mg), Ritonavir (10mg), Abacavir (30mg) and Lamivudine (15mg) in granules formulation. Dosage according to patient's weight: Between 3 and 5.9kg: 2 capsules twice a day Between 6 and 9.9kg: 3 capsules twice a day Between 10 and 13.9kg: 4 capsules twice a day Between 14 and 19.9kg: 5 capsules twice a day Between 20 and 24.9kg: 6 capsules twice a day	Drug	4in1 granules, LPV/r Pellets Plus ABC/3TC
LPV/r Pellets (40/10mgs) plus ABC/3TC (60/30mgs)Also: L PV/r Pellets Plus ABC/3TC tabletsLopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg dispersible tablets) Dosage according to patient's weight: LPV/r Pellets: Between 3 and 5.9kg: 2 capsules twice a day Between 6 and 9.9kg: 3 capsules twice a day Between 10 and 13.9kg: 4 capsules twice a day Between 14 and 19.9kg: 5 capsules twice a day Between 20 and 24.9kg: 6 capsules twice a day ABC/3TC: Between 3 and 5.9kg: 1 tablet twice a day Between 6 and 9.9kg: 1.5 tablets twice a day Between 10 and 13.9kg: 2 tablets twice a day Between 14 and 19.9kg: 2.5 tablets twice a day Between 20 and 24.9kg: 3 tablets twice a day	Drug	4in1 granules, LPV/r Pellets Plus ABC/3TC

Primary outcome

0 -12 hours Area under the curve plasma concentration versus time for LPV, ABC and 3TC in the 4-in- formulation
Time frame: 0-12 hours
0 -12 hours Area under the curve plasma concentration versus time for LPV, ABC and 3TC in the 4-in- formulation

14 secondary outcomes

Plasma concentration at 12 hours for LPV in the 4in1 formulation
Time frame: 12 hours
Peak plasma concentration (Cmax) of LPV, ABC and 3TC with the 4-in-1 formulation.
Time frame: 3-5 weeks
Concentration time maximum for LPV, ABC and 3TC with the 4-in-1 formulation.
Time frame: 3-5 weeks
Clearance function for LPV, ABC and 3TC with the 4-in-1 formulation.
Time frame: 3-5 weeks
Geometric mean ratio (GMR) of steady state LPV, ABC and 3TC versus time (0-12) in the 4-in-1 formulation versus the reference treatment regimen
Time frame: 0 - 12 hours
Area under curve plasma concentration versus time (0-12) in the 4-in-1 formulation versus the reference treatment regimen.
Time frame: 0 - 12 hours
Geometric mean ratio (GMR) of steady state LPV, ABC and 3TC in the 4-in-1 formulation versus the reference treatment regimen.
Time frame: 0 - 12 hours
Peak plasma concentration in the 4-in-1 formulation versus the reference treatment regimen.
Time frame: 3-5 weeks
Safety: A description of the proportion of children experiencing an Adverse event or Serious Adverse event binomial distribution compared between the two formulations.
Time frame: 6-8 weeks
Safety: Summary of the number and percent of subjects with documented Grade 3 or higher adverse events; each summary will be conducted overall and by formulation
Time frame: 6-8 weeks
Proportion of children with viral load <1000 copies/ml
Time frame: 6-8 weeks
Changes in CD4 counts compared to baseline
Time frame: 6-8 week
Changes in CD4 percentage compared to baseline
Time frame: 6-8 weeks
Acceptability: Description of factors that affect acceptability of the 4 in1 formulation
Time frame: 6-8 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
Derived from this study: PubMed 36968554Rotsaert A, Ogara C, Mwanga-Amumpaire J, Kekitiinwa AR, Musiime V, Najjingo E, Kisitu GP, Nazzinda R, Nambi E, Lee J, Diallo M, Kyomuhendo F, Waweru M, Andrieux-Meyer I, Nostlinger C. Acceptability of a new 4-in-1 Abacavir/Lamivudine/Lopinavir/Ritonavir paediatric fixed-dose combination: the caregiver-child dyads' perspective. Ther Adv Infect Dis. 2023 Mar 21;10:20499361231159993. doi: 10.1177/20499361231159993. eCollection 2023 Jan-Dec.
Individual participant dataSharing planned: Undecided

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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.

Isabelle Andrieux-Meyer, MD contact

+41 22 906 92 68

iandrieux-meyer@dndi.org

Isabelle Andrieux-Meyer, MD study director

Drugs for Neglected Diseases initiative

3 sites 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 ABC/3TC/LPV/r granules (30/15/40/10 mgs) and LPV/r Pellets (40/10mgs) plus ABC/3TC (60/30mgs) in people with HIV, run by Drugs for Neglected Diseases at 3 sites in Uganda.

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 7 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 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Uganda. 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 Isabelle Andrieux-Meyer, MD (+41 22 906 92 68, iandrieux-meyer@dndi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

0 -12 hours Area under the curve plasma concentration versus time for LPV, ABC and 3TC in the 4-in- formulation (time frame: 0-12 hours). 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 NCT03836833, which also lists 1 linked publication.

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 7 Jun 2019.