MalariaPhase 1DolACTNCT02242799
Dolutegravir Interactions With Artemisinin-based Combination Therapies
A Phase 1 study testing Dolutegravir 50mg od, Artemether-lumefantrine combination and Artesunate-amodiaquine in people with Malaria and HIV, run by University of Liverpool at 1 site in Uganda.
Trial summary
Malaria and HIV are found in the same regions of the world and developing countries are most affected by both diseases. For malaria, new drugs have been introduced called ACTs. These drugs are effective against malaria but little is known about how the levels of these drugs in blood relate to how effective these drugs… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Dolutegravir 50mg od, Artemether-lumefantrine combination and Artesunate-amodiaquine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUganda
- Study dates
- Jun 2015to Sep 2016
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.
- Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Men and women aged 18 years and above
- Weight ≥40 kg
- HIV antibody negative at screening.
- Malaria blood film negative at screening
- Willing to use mosquito bednets routinely for the duration of the study
- Women of childbearing potential must be willing to use an effective barrier contraception method for the duration of the study.
Who cannot join
- Significant disease affecting cardiac, respiratory, gastrointestinal or neurological symptoms which in the clinician's medical judgment could be worsened by participating in this study or the presence of medical or surgical conditions which could prevent the subject from complying with study procedures.
- Serum alanine transaminase (ALT) levels above 3x upper limit of normal
- Serum creatinine levels above 2x upper limit of normal
- Hepatitis B surface antigen positive
- Use of medications which are known inducers/inhibitors of CYP or glucuronyl transferase UGT1A1 within past 2 months (e.g. anticonvulsants, TB medications, HIV agents for prophylaxis, azole antifungals)
- Evidence of QT prolongation on electrocardiogram (ECG) QTc (Rate adjusted QT interval) >450ms (men) or >470ms (women)
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- Pregnant women or female subjects who are unwilling to use a suitable contraceptive method for the duration of the study (condom, diaphragm, IUD or contraceptive implant)
- Likely to be poorly adherent based on clinician's medical judgement
- Known to be current injection drug user
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Dolutegravir Interactions With Artemether-Lumefantrine and Amodiaquine-Artesunate
Malaria and HIV are found in the same regions of the world and developing countries are most affected by both diseases. For malaria, new drugs have been introduced called ACTs. These drugs are effective against malaria but little is known about how the levels of these drugs in blood relate to how effective these drugs are. For HIV, a new drug has been developed called dolutegravir which has potential to be widely used in developing countries. This proposal will explore how dolutegravir affects the drug levels of these antimalarial drugs and vice versa. In total, 46 healthy volunteers will participate in this study.
Read the detailed description
More than 90% of the malaria occurs in sub-Saharan Africa (WHO 2008), the region bearing 67% of the global HIV burden (WHO 2011). Given the extensive overlap in geographical distribution of these diseases, interactions between them could have profound public health consequences. Significant biological interactions exist between HIV and malaria. HIV is known to increase susceptibility to malaria infection (Whitworth, Morgan et al. 2000), compromise the host's ability to clear malaria parasites (characterised by higher parasite densities) (Francesconi, Fabiani et al. 2001), increase the risk of symptomatic malaria and contribute to malaria treatment failure (Hewitt, Steketee et al. 2006). In areas of unstable transmission, malaria mortality is higher in HIV-positive individuals. Additionally, placental malaria infection in HIV positive individuals is associated with higher perinatal mortality, low birth weight and HIV transmission, and this effect is not attenuated in subsequent pregnancies, in contrast with HIV-negative individuals. Conversely, malaria infection has been shown to increase HIV viral load (Hoffman, Jere et al. 1999, Kublin, Patnaik et al. 2005), with the potential for both accelerated HIV disease progression and increased HIV transmission (Abu-Raddad, Patnaik et al. 2006).
As of September 2011, Uganda had 1.4 million people living with HIV/AIDS; of those with clinically advanced disease, 54% (313 117) were receiving ART (WHO). As southern African countries are scaling up coverage of ART, they have also stepped up the fight against Pf malaria by increasing the coverage of Insecticide Treated Nets and by adopting the use of artemisinin-based combination therapies (ACTs) as first line treatment of malaria (USAID 2011). AL and AS-AQ are the most commonly utilized regimens in sub-Saharan Africa for first line treatment for malaria (WHO 2008).
As a consequence of high rates of HIV-malaria co-infection and increasing availability of both ACTs and ART in southern Africa, progressively more co-infected people will receive both classes of drugs. However, the pharmacokinetics, safety and/or efficacy of ACTs such as AL, AS-AQ and DHA-piperaquine in HIV-infected individuals who are on ART are poorly understood. Many efficacy studies conducted as part of the drug development process of ACTs have either not assessed the HIV status of study participants or systematically excluded HIV-infected individuals. Few studies have systematically evaluated for potential drug-drug interactions in a healthy volunteer setting.
Study Design
Open label, fixed sequence healthy volunteer study to compare pharmacokinetic interactions between DTG and AL (Study A; crossover design), or AS-AQ (Study B; parallel group design). Whilst a cross-over study design would be theoretically ideal for investigating both ACTs in combination with DTG, desethylamodiaquine, an active metabolite of AQ has an extensive terminal t1/2 of approximately 10 days; therefore it is not considered feasible to undertake a cross-over design for this arm of the study, since the washout period between the two phases would exceed two months, risking subject attrition. Furthermore, during that time period, intercurrent illnesses and other important changes may occur within a subject, leading changes in eligibility for the study. Therefore, two study designs are planned as detailed in the Study Design Section.
- Being tested
- Dolutegravir 50mg od, Artemether-lumefantrine combination, Artesunate-amodiaquine
- Keywords
- Malaria, HIV, Dolutegravir, Artemisinin, Pharmacokinetics, Interactions
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dolutegravir 50mg odDrug
Also called Tivicay, ViiV Healthcare, GSK1349572
Dolutegravir 50mg once daily will be given either alone or in combination, as specified
Artemether-lumefantrine combinationDrug
Also called Co-artem
Artemether-lumefantrine combination will be given both alone and in combination with Dolutegravir 50mg od in order to assess changes in PK
Artesunate-amodiaquineDrug
Also called Coarsucam
Artesunate-amodiaquine will be given alone or in combination with Dolutegravir 50mg od (in a parallel study design) in order to assess the potential interaction causing changes in PK parameters
| Study group | Role | What they receive |
|---|---|---|
| Study A Sequence 1 | Experimental | Artemether-lumefantrine combination alone for 3 days with PK sampling at steady state, then 21 day washout period followed by Dolutegravir 50mg od dosing to steady state (7 days) with PK sampling then a further 3 days where Artemether-lumefantrine combination and Dolutegravir 50mg od are given together, with PK sampling at steady state. Receives: Drug: Dolutegravir 50mg od; Drug: Artemether-lumefantrine combination |
| Study A Sequence 2 | Experimental | Dolutegravir 50mg od given for 7 days with PK sampling at steady state, followed immediately by a further 3 days where Artemether-lumefantrine combination and Dolutegravir 50mg od are given together, again with PK sampling at steady state. Following a 21 day washout period, the subject will then receive Artemether-lumefantrine combination alone for 3 days, with PK sampling at steady state. Receives: Drug: Dolutegravir 50mg od; Drug: Artemether-lumefantrine combination |
| Study B Sequence 1 | Experimental | Administration of artesunate-amodiaquine for 3 days with PK sampling at steady state Receives: Drug: Artesunate-amodiaquine |
| Study B Sequence 2 | Experimental | Dolutegravir alone for 7 days with PK sampling at steady state, followed immediately by administration of both artesunate-amodiaquine and dolutegravir together for a further 3 days with PK sampling at steady state Receives: Drug: Dolutegravir 50mg od; Drug: Artesunate-amodiaquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in area under time-concentration curve [AUC] of DTG and antimalarial drugs
When subjects are at steady state (of single drug or combination, as detailed in the study design section) intensive PK sampling will be performed
Measured: At steady state (after 3 days dosing for antimalarials and 7 days for DTG)
Change in maximum concentration [Cmax] of DTG and antimalarials
PK sampling will be done when each drug is at presumed 'steady state'
Measured: At steady state (3 days for antimalarials and 7 days for DTG)
Change in time to maximum concentration [Tmax] for antimalarials and DTG
Medications will be dosed up to steady state before PK sampling is undertaken
Measured: At steady state (3 days for antimalarials and 7 days for DTG)
Change in clearance [Cl/F] for antimalarials and DTG
Medications will be dosed up to steady state prior to PK sampling
Measured: Steady state - 3 days for antimalarials and 7 days for dolutegravir
Change in trough concentration [Ctrough]) for antimalarial drugs and DTG
PK sampling will be performed at steady state
Measured: Steady state - 3 days for antimalarials and 7 days for DTG
Secondary outcomes (1)
Safety and tolerability of the drug combinations
Patients will be assessed clinically to identify safety concerns, panels of 'safety bloods' will be performed at the time of rich PK sampling, and 12 lead ECGs will assess potential effects of the drugs/ combinations on the QT interval
Measured: Until 2 weeks after all medication has been discontinued at the end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startJun 2015
- Primary completionSep 2016
- Study completionSep 2016
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 MalariaStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare, Makerere University
- Responsible party
- Principal investigator, Catriona Waitt, University of Liverpool
- Investigators
- Mohammed Lamorde, PhD, MBChB, Study director, Infectious Diseases InstituteSaye H Khoo, FRCP, PhD, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242799
- Sponsor's protocol ID
- PK13
- Acronym
- DolACT
- Status last verified
- Oct 2016
- First submitted
- 13 Sep 2014
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Walimbwa SI, Lamorde M, Waitt C, Kaboggoza J, Else L, Byakika-Kibwika P, Amara A, Gini J, Winterberg M, Chiong J, Tarning J, Khoo SH. Drug Interactions between Dolutegravir and Artemether-Lumefantrine or Artesunate-Amodiaquine. Antimicrob Agents Chemother. 2019 Jan 29;63(2):e01310-18. doi: 10.1128/AAC.01310-18. Print 2019 Feb.
PubMed 30420479
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dolutegravir Interactions With Artemether-Lumefantrine and Amodiaquine-Artesunate
- ClinicalTrials.gov ID
- NCT02242799
- Acronym / sponsor ID
- DolACT / PK13
- Keywords
- Malaria, HIV, Dolutegravir, Artemisinin, Pharmacokinetics, Interactions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Collaborators
- ViiV Healthcare, Makerere University
- Study start
- Jun 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 17 Sep 2014 (estimated)
- 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.
Malaria and HIV are found in the same regions of the world and developing countries are most affected by both diseases. For malaria, new drugs have been introduced called ACTs. These drugs are effective against malaria but little is known about how the levels of these drugs in blood relate to how effective these drugs are. For HIV, a new drug has been developed called dolutegravir which has potential to be widely used in developing countries. This proposal will explore how dolutegravir affects the drug levels of these antimalarial drugs and vice versa. In total, 46 healthy volunteers will participate in this study.
Detailed description
More than 90% of the malaria occurs in sub-Saharan Africa (WHO 2008), the region bearing 67% of the global HIV burden (WHO 2011). Given the extensive overlap in geographical distribution of these diseases, interactions between them could have profound public health consequences. Significant biological interactions exist between HIV and malaria. HIV is known to increase susceptibility to malaria infection (Whitworth, Morgan et al. 2000), compromise the host's ability to clear malaria parasites (characterised by higher parasite densities) (Francesconi, Fabiani et al. 2001), increase the risk of symptomatic malaria and contribute to malaria treatment failure (Hewitt, Steketee et al. 2006). In areas of unstable transmission, malaria mortality is higher in HIV-positive individuals. Additionally, placental malaria infection in HIV positive individuals is associated with higher perinatal mortality, low birth weight and HIV transmission, and this effect is not attenuated in subsequent pregnancies, in contrast with HIV-negative individuals. Conversely, malaria infection has been shown to increase HIV viral load (Hoffman, Jere et al. 1999, Kublin, Patnaik et al. 2005), with the potential for both accelerated HIV disease progression and increased HIV transmission (Abu-Raddad, Patnaik et al. 2006).
As of September 2011, Uganda had 1.4 million people living with HIV/AIDS; of those with clinically advanced disease, 54% (313 117) were receiving ART (WHO). As southern African countries are scaling up coverage of ART, they have also stepped up the fight against Pf malaria by increasing the coverage of Insecticide Treated Nets and by adopting the use of artemisinin-based combination therapies (ACTs) as first line treatment of malaria (USAID 2011). AL and AS-AQ are the most commonly utilized regimens in sub-Saharan Africa for first line treatment for malaria (WHO 2008).
As a consequence of high rates of HIV-malaria co-infection and increasing availability of both ACTs and ART in southern Africa, progressively more co-infected people will receive both classes of drugs. However, the pharmacokinetics, safety and/or efficacy of ACTs such as AL, AS-AQ and DHA-piperaquine in HIV-infected individuals who are on ART are poorly understood. Many efficacy studies conducted as part of the drug development process of ACTs have either not assessed the HIV status of study participants or systematically excluded HIV-infected individuals. Few studies have systematically evaluated for potential drug-drug interactions in a healthy volunteer setting.
Study Design
Open label, fixed sequence healthy volunteer study to compare pharmacokinetic interactions between DTG and AL (Study A; crossover design), or AS-AQ (Study B; parallel group design). Whilst a cross-over study design would be theoretically ideal for investigating both ACTs in combination with DTG, desethylamodiaquine, an active metabolite of AQ has an extensive terminal t1/2 of approximately 10 days; therefore it is not considered feasible to undertake a cross-over design for this arm of the study, since the washout period between the two phases would exceed two months, risking subject attrition. Furthermore, during that time period, intercurrent illnesses and other important changes may occur within a subject, leading changes in eligibility for the study. Therefore, two study designs are planned as detailed in the Study Design Section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Study A Sequence 1 | Experimental | Drug: Dolutegravir 50mg od, Drug: Artemether-lumefantrine combinationArtemether-lumefantrine combination alone for 3 days with PK sampling at steady state, then 21 day washout period followed by Dolutegravir 50mg od dosing to steady state (7 days) with PK sampling then a further 3 days where Artemether-lumefantrine combination and Dolutegravir 50mg od are given together, with PK sampling at steady state. |
| Study A Sequence 2 | Experimental | Drug: Dolutegravir 50mg od, Drug: Artemether-lumefantrine combinationDolutegravir 50mg od given for 7 days with PK sampling at steady state, followed immediately by a further 3 days where Artemether-lumefantrine combination and Dolutegravir 50mg od are given together, again with PK sampling at steady state. Following a 21 day washout period, the subject will then receive Artemether-lumefantrine combination alone for 3 days, with PK sampling at steady state. |
| Study B Sequence 1 | Experimental | Drug: Artesunate-amodiaquineAdministration of artesunate-amodiaquine for 3 days with PK sampling at steady state |
| Study B Sequence 2 | Experimental | Drug: Dolutegravir 50mg od, Drug: Artesunate-amodiaquineDolutegravir alone for 7 days with PK sampling at steady state, followed immediately by administration of both artesunate-amodiaquine and dolutegravir together for a further 3 days with PK sampling at steady state |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.
- Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Men and women aged 18 years and above
- Weight ≥40 kg
- HIV antibody negative at screening.
Key exclusion criteria (9 listed)
- Significant disease affecting cardiac, respiratory, gastrointestinal or neurological symptoms which in the clinician's medical judgment could be worsened by participating in this study or the presence of medical or surgical conditions which could prevent the subject from complying with study procedures.
- Serum alanine transaminase (ALT) levels above 3x upper limit of normal
- Serum creatinine levels above 2x upper limit of normal
- Hepatitis B surface antigen positive
- Use of medications which are known inducers/inhibitors of CYP or glucuronyl transferase UGT1A1 within past 2 months (e.g. anticonvulsants, TB medications, HIV agents for prophylaxis, azole antifungals)
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 |
|---|---|---|
| Dolutegravir 50mg odAlso: Tivicay, ViiV Healthcare, GSK1349572Dolutegravir 50mg once daily will be given either alone or in combination, as specified | Drug | Study A Sequence 1, Study A Sequence 2, Study B Sequence 2 |
| Artemether-lumefantrine combinationAlso: Co-artemArtemether-lumefantrine combination will be given both alone and in combination with Dolutegravir 50mg od in order to assess changes in PK | Drug | Study A Sequence 1, Study A Sequence 2 |
| Artesunate-amodiaquineAlso: CoarsucamArtesunate-amodiaquine will be given alone or in combination with Dolutegravir 50mg od (in a parallel study design) in order to assess the potential interaction causing changes in PK parameters | Drug | Study B Sequence 1, Study B Sequence 2 |
Primary outcome
Change in area under time-concentration curve [AUC] of DTG and antimalarial drugs
Time frame: At steady state (after 3 days dosing for antimalarials and 7 days for DTG)
When subjects are at steady state (of single drug or combination, as detailed in the study design section) intensive PK sampling will be performed
Change in maximum concentration [Cmax] of DTG and antimalarials
Time frame: At steady state (3 days for antimalarials and 7 days for DTG)
PK sampling will be done when each drug is at presumed 'steady state'
Change in time to maximum concentration [Tmax] for antimalarials and DTG
Time frame: At steady state (3 days for antimalarials and 7 days for DTG)
Medications will be dosed up to steady state before PK sampling is undertaken
Change in clearance [Cl/F] for antimalarials and DTG
Time frame: Steady state - 3 days for antimalarials and 7 days for dolutegravir
Medications will be dosed up to steady state prior to PK sampling
Change in trough concentration [Ctrough]) for antimalarial drugs and DTG
Time frame: Steady state - 3 days for antimalarials and 7 days for DTG
PK sampling will be performed at steady state
1 secondary outcome
Safety and tolerability of the drug combinations
Time frame: Until 2 weeks after all medication has been discontinued at the end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
- Derived from this study: PubMed 30420479Walimbwa SI, Lamorde M, Waitt C, Kaboggoza J, Else L, Byakika-Kibwika P, Amara A, Gini J, Winterberg M, Chiong J, Tarning J, Khoo SH. Drug Interactions between Dolutegravir and Artemether-Lumefantrine or Artesunate-Amodiaquine. Antimicrob Agents Chemother. 2019 Jan 29;63(2):e01310-18. doi: 10.1128/AAC.01310-18. Print 2019 Feb.
- Dolutegravir product informationLink provided by the sponsor.
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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.
Mohammed Lamorde, PhD, MBChB study director
Infectious Diseases Institute
Saye H Khoo, FRCP, PhD principal investigator
University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dolutegravir 50mg od, Artemether-lumefantrine combination and Artesunate-amodiaquine in people with Malaria and HIV, run by University of Liverpool at 1 site 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 8 inclusion and 9 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: finished, as of the sponsor's last update on 5 Oct 2016. 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 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in area under time-concentration curve [AUC] of DTG and antimalarial drugs (time frame: At steady state (after 3 days dosing for antimalarials and 7 days for DTG)). The study lists 5 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 NCT02242799, 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 5 Oct 2016.