HIV CoinfectionPhase 4OPTIMALNCT04708496
Optimizing Malaria Treatment for HIV-Malaria Co-infected Individuals
A Phase 4 study testing Artemether-lumefantrine in people with HIV Coinfection and Malaria, run by Makerere University at 2 sites in Uganda.
Trial summary
Optimal is a Randomized clinical trial to optimize treatment of malaria in HIV -malaria co infected patients. It has been demonstrated that, when the antimalarial drug Artemether Lumefantrine is co administered with Efavirenz based ART in HIV-malaria co-infected individuals, sub therapeutic levels of the drug are… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Coinfection, Malaria
- What is being tested?
- Artemether-lumefantrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 888 participants
- Where
- 2 sitesUganda
- Study dates
- 18 Jan 2021to Mar 2024
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Willing and able to comply with study treatment and procedures
- Age above 18 years
- Confirmed HIV positive and receiving efavirenz or dolutegravir based ART for objectives 3 and 4
- Confirmed Malaria blood film positive without evidence for severe malaria for objectives 3 and 4
- Confirmed Malaria blood film negative for objectives 1 and 2
Who cannot join
- Serum alanine transaminase levels above 3x upper limit of normal
- Serum creatinine levels above 2x upper limit of normal
- Use of known inducers/inhibitors of CYP or glucuronyl transferase UGT1A1 within past 2 months (e.g. anticonvulsants, TB medications, HIV agents for prophylaxis, azole antifungals)
- 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
Show all 11Show fewer
- Administration of any additional antimalarial drugs that are not study drugs within 24 hours before study enrollment and during the course of the study.
- Presence of any non-malarial febrile illness which may interfere with the classification of malaria treatment outcome
- Movement away from the study area interfering with follow-up assessment
- Patients with contraindications to taking the study drugs
- Evidence of QT prolongation on ECG (rate adjusted QT interval>45ms (men (or >470ms for women
Trial locations and contacts
2 sites in 1 country.
Uganda2 sites, 1 recruiting
- Completed
Infectious Diseases Institute
Kampala
- Recruiting
Tororo District Hospital
Tororo, P.O Box 1
Pauline Byakika-Kibwika, PHD, 077262688, pbyakika@gmail.com
Fiona Eyotaru, MBchB, 0776576452, feyotaru@idi.co.ug
About this study
Official title: Optimizing Malaria Treatment for HIV-Malaria Co-Infected Individuals by Addressing Drug Interactions Between Artemether-Lumefantrine and Efavirenz; a Randomized Controlled Trial
Optimal is a Randomized clinical trial to optimize treatment of malaria in HIV -malaria co infected patients. It has been demonstrated that, when the antimalarial drug Artemether Lumefantrine is co administered with Efavirenz based ART in HIV-malaria co-infected individuals, sub therapeutic levels of the drug are achieved hence resulting in poor malaria treatment outcomes.
The study then hypothesizes that, : HIV-malaria co-infected individuals receiving efavirenz-based ART plus a double-dose or 5-day course of artemether-lumefantrine will achieve higher and adequate artemether-lumefantrine serum concentrations with adequate 42-day treatment outcomes compared to individuals with HIV-malaria co-infection receiving efavirenz-based ART plus a standard-dose of artemether-lumefantrine.
Read the detailed description
Malaria and HIV have significant interactions at various levels. The geographical and epidemiological overlap increases risk for co-infection and co-treatment. The immune suppression due to HIV increases malaria incidence, severity and risk for poor treatment outcomes including mortality and adverse pregnancy outcomes such as anemia and low birth weight. Malaria infection increases HIV viral replication. Both malaria and HIV are treated with combination therapy to enhance treatment outcomes and reduce risk for development of resistance, consequently creating potential for drug-drug interactions (DDIs) when the two diseases are treated concomitantly. Previous studies demonstrated significant reduction in systemic exposure to Artemether, its metabolite dihydroartemisinin, and the long acting partner drug lumefantrine when the ACT artemether-lumefantrine was co-administered with efavirenz-based ART to HIV-malaria co-infected individuals.
Exposure to sub therapeutic antimalarial drug concentrations poses a risk for poor malaria treatment outcomes such as prolonged morbidity, anemia, death and poor birth outcomes for pregnant women plus increased economic costs and risk for drug resistance. There are currently limited drug options available for both malaria and HIV treatment especially in sub-Saharan Africa, thus the need to protect drug effectiveness. There are very scanty data on effects of drug interactions on malaria clinical outcomes, and such studies would be unethical currently. Despite these gaps, co-administration of antimalarial and antiretroviral drugs occurs with no guidance on therapeutic interventions to overcome these deleterious effects. Data are therefore urgently needed to optimize treatment of malaria for HIV-malaria co-infected individuals.
General Objective: To utilize innovative interventions to overcome drug interactions between artemether-lumefantrine and efavirenz to guide malaria treatment for individuals co-infected with HIV and malaria.
Specific objectives:
Objectives
- To determine the safety and Pharmacokinetics of the double dose artemether-lumefantrine when administered to healthy volunteers (malaria negative and HIV negative individuals).
- To determine the safety and Pharmacokinetics of the 5-day course of artemether-lumefantrine when administered to healthy volunteers (malaria negative and HIV negative individuals).
- To determine the safety, pharmacokinetics and malaria treatment outcome of a standard dose of artemether-lumefantrine compared to double of the standard dose for weight and a 5-day course of artemether-lumefantrine for treatment of uncomplicated malaria among HIV-Malaria co-infected individuals receiving efavirenz (400mg) based ART.
- To determine the safety and Pharmacokinetics of artemether-lumefantrine when administered with Dolutegravir based ART among HIV-malaria co-infected individuals.
- Conditions
- HIV Coinfection, Malaria
- Being tested
- Artemether-lumefantrine
- Medical subject headings
- HIV Infections, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemether-lumefantrineDrug
Also called Efavirenz, Dolutegravir
A three-arm single blind Randomized Clinical Trial in which HIV-malaria co-infected individuals with uncomplicated malaria receiving efavirenz-based ART will be randomized to one of three arms; a standard dose of artemether-lumefantrine, or a double dose of artemether-lumefantrine, or a 5-day course of artemether-lumefantrine for treatment of uncomplicated malaria. Participants will be followed up for 42 days to determine safety, drug pharmacokinetics and malaria treatment outcomes.
The 4th objective focuses on the interaction between Dolutegravir and Artemether Lumefantrine hence this will be a single blind pharmacokinetic trial among HIV-malaria co-infected individuals receiving Dolutegravir based ART and standard dose of artemether-lumefantrine for treatment of uncomplicated malaria.
| Study group | Role | What they receive |
|---|---|---|
| Standard dose of Artemether lumefantrine | Experimental | Dose comparison-concurrent control In this arm, Participants receiving Efavirenz400mg based ART will be randomized to standard dose Artemether Lumefantrine when treating uncomplicated malaria in HIV-malaria co-infected participants Receives: Drug: Artemether-lumefantrine |
| Double dose Artemether lumefantrine | Experimental | Dose comparison concurrent control In this arm, Participants receiving Efavirenz based ART will be randomized to double dose Artemether Lumefantrine when treating uncomplicated malaria in HIV-malaria co-infected participants Receives: Drug: Artemether-lumefantrine |
| 5 day course of Artemether lumefantrine | Experimental | Dose comparison concurrent control In this arm, Participants receiving Efavirenz based ART will be randomized to 5 day course of Artemether Lumefantrine as opposed to the standard 3day course when treating uncomplicated malaria in HIV-malaria co-infected participants Receives: Drug: Artemether-lumefantrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of malaria treatment outcome adjusted by genotyping and classified as reinfection or recrudescence.
The Primary outcome measure will be the malaria treatment outcome adjusted by genotyping and classified as reinfection or recrudescence.
Treatment outcomes will be classified on the basis of an assessment of the parasitological and clinical outcomes of antimalarial treatment according to the latest WHO guidelines. Thus, all patients will be classified as having early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response.
Clinical Treatment outcomes will be assessed according to WHO criteria as; early treatment failure and late treatment failure. Parasitological treatment outcomes will be classified as late parasitological failure and adequate clinical and parasitological response.
Measured: Day 42
Secondary outcomes (9)
Change Maximum concentration [Cmax] of the antimalarials (Artemether, dihydroartemisinin [DHA], lumefantrin and desbutylumefantrine
Plots of plasma concentration versus time curves will be produced for artemether, dihydroartemisinin, lumefantrine and desbutyl-lumefantrine. Pharmacokinetic parameter Cmax derived directly from the data. The Cmax pharmacokinetic parameter will be presented using descriptive summary statistics including geometric means, geometric mean ratios (GMR) and confidence intervals (CI), or medians and interquartile ranges. The CIs will be determined using logarithms of the individual geometric mean values; the calculated values will be then expressed as linear values.
Measured: over 120hours
Measuring level of Hemoglobin
Anemia is a common with Malaria. The hemoglobin levels will be measured to assess for any reduction and also recovery of the hemoglobin level following treatment.
Measured: Hemoglobin will be measured from on follow-up days; 7, 14, 21 and 28.
Change in Area under the time-concentration curve [AUC] of the antimalarials (Artemether, dihydroartemisinin [DHA], lumefantrin and desbutylumefantrine
Plots of plasma concentration versus time curves will be produced for artemether. AUC over 24 hours (AUC0-24) will be calculated using non-compartmental methods (WinNonlin® Version 6.2, Pharsight). The pharmacokinetic parameter will be presented using descriptive summary statistics including geometric means, geometric mean ratios (GMR) and confidence intervals (CI), or medians and interquartile ranges. The CIs will be determined using logarithms of the individual geometric mean values; the calculated values will be then expressed as linear values.
Measured: over 120hours
Change in Time to maximum concentration [Tmax] of the antimalarials (Artemether, dihydroartemisinin [DHA], lumefantrin and desbutylumefantrine)
Plots of plasma concentration versus time curves will be produced for artemether, dihydroartemisinin, lumefantrine and desbutyl-lumefantrine. Pharmacokinetic parameter time to maximal concentration (Tmax) will be derived directly from the data. The pharmacokinetic parameter will be presented using descriptive summary statistics including geometric means, geometric mean ratios (GMR) and confidence intervals (CI), or medians and interquartile ranges. The CIs will be determined using logarithms of the individual geometric mean values; the calculated values will be then expressed as linear values.
Measured: over 120hours
Change in Clearance [Cl/F] of the antimalarials (Artemether, dihydroartemisinin [DHA], lumefantrin and desbutylumefantrine)
Plots of plasma concentration versus time curves will be produced for artemether, dihydroartemisinin, lumefantrine and desbutyl-lumefantrine. The apparent oral clearance will be calculated using non-compartmental methods (WinNonlin® Version 6.2, Pharsight). This pharmacokinetic parameter will be presented using descriptive summary statistics including geometric means, geometric mean ratios (GMR) and confidence intervals (CI), or medians and interquartile ranges. The CIs will be determined using logarithms of the individual geometric mean values; the calculated values will be then expressed as linear values.
Measured: over 120hours
Change in Trough concentration [Ctrough]) of the antimalarials (Artemether, dihydroartemisinin [DHA], lumefantrin and desbutylumefantrine)
Plots of plasma concentration versus time curves will be produced for artemether, dihydroartemisinin, lumefantrine and desbutyl-lumefantrine. The change in trough concentration will be presented using descriptive summary statistics including geometric means, geometric mean ratios (GMR) and confidence intervals (CI), or medians and interquartile ranges. The CIs will be determined using logarithms of the individual geometric mean values; the calculated values will be then expressed as linear values.
Measured: over 120hours
Prolongation of the QT interval
ECG Monitoring A 12-lead ECG to monitor for QT prolongation will be performed. If any prolongation of the QT interval is observed, the ECGs will be performed at every study visit until normalization.
Measured: Over 35days
Change in the level on the liver enzymes ALT and ALP
Liver Function will be assessed at screening, and on days 7 and 35. Should any derangement in function be observed, the same will be performed at every study visit until normalization. Any participant with deranged liver function will be reported to have either adverse event or serious adverse event depending on the degree of severity and will be further assessed, treated appropriately and followed up till resolution
Measured: Over 35days
Change in creatinine and urea levels
Renal Function will be assessed at screening, and on days 7 and 35. Should any derangement in function be observed, the same will be performed at every study visit until normalization. Any participant with deranged renal function (Creatinine and urea levels) will be reported to have either adverse event or serious adverse event depending on the degree of severity and will be further assessed, treated appropriately and followed up till resolution" Focus will be on monitoring change
Measured: Over 35days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start18 Jan 2021
- Primary completionJan 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV CoinfectionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A three arm single blind randomized trial. Study participants will be randomized to one of the 3 arms. Standard dose, double dose or 5 day course of Artemether-lumefantrine
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 888 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pauline Byakika-Kibwika, PHD, Principal investigator, IDI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708496
- Sponsor's protocol ID
- PK25
- Acronym
- OPTIMAL
- Status last verified
- Jan 2022
- First submitted
- 12 Nov 2020
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Malaria Treatment for HIV-Malaria Co-Infected Individuals by Addressing Drug Interactions Between Artemether-Lumefantrine and Efavirenz; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04708496
- Acronym / sponsor ID
- OPTIMAL / PK25
- Conditions
- HIV Coinfection, Malaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 888 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 14 Jan 2021 (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.
Optimal is a Randomized clinical trial to optimize treatment of malaria in HIV -malaria co infected patients. It has been demonstrated that, when the antimalarial drug Artemether Lumefantrine is co administered with Efavirenz based ART in HIV-malaria co-infected individuals, sub therapeutic levels of the drug are achieved hence resulting in poor malaria treatment outcomes.
The study then hypothesizes that, : HIV-malaria co-infected individuals receiving efavirenz-based ART plus a double-dose or 5-day course of artemether-lumefantrine will achieve higher and adequate artemether-lumefantrine serum concentrations with adequate 42-day treatment outcomes compared to individuals with HIV-malaria co-infection receiving efavirenz-based ART plus a standard-dose of artemether-lumefantrine.
Detailed description
Malaria and HIV have significant interactions at various levels. The geographical and epidemiological overlap increases risk for co-infection and co-treatment. The immune suppression due to HIV increases malaria incidence, severity and risk for poor treatment outcomes including mortality and adverse pregnancy outcomes such as anemia and low birth weight. Malaria infection increases HIV viral replication. Both malaria and HIV are treated with combination therapy to enhance treatment outcomes and reduce risk for development of resistance, consequently creating potential for drug-drug interactions (DDIs) when the two diseases are treated concomitantly. Previous studies demonstrated significant reduction in systemic exposure to Artemether, its metabolite dihydroartemisinin, and the long acting partner drug lumefantrine when the ACT artemether-lumefantrine was co-administered with efavirenz-based ART to HIV-malaria co-infected individuals.
Exposure to sub therapeutic antimalarial drug concentrations poses a risk for poor malaria treatment outcomes such as prolonged morbidity, anemia, death and poor birth outcomes for pregnant women plus increased economic costs and risk for drug resistance. There are currently limited drug options available for both malaria and HIV treatment especially in sub-Saharan Africa, thus the need to protect drug effectiveness. There are very scanty data on effects of drug interactions on malaria clinical outcomes, and such studies would be unethical currently. Despite these gaps, co-administration of antimalarial and antiretroviral drugs occurs with no guidance on therapeutic interventions to overcome these deleterious effects. Data are therefore urgently needed to optimize treatment of malaria for HIV-malaria co-infected individuals.
General Objective: To utilize innovative interventions to overcome drug interactions between artemether-lumefantrine and efavirenz to guide malaria treatment for individuals co-infected with HIV and malaria.
Specific objectives:
Objectives
- To determine the safety and Pharmacokinetics of the double dose artemether-lumefantrine when administered to healthy volunteers (malaria negative and HIV negative individuals).
- To determine the safety and Pharmacokinetics of the 5-day course of artemether-lumefantrine when administered to healthy volunteers (malaria negative and HIV negative individuals).
- To determine the safety, pharmacokinetics and malaria treatment outcome of a standard dose of artemether-lumefantrine compared to double of the standard dose for weight and a 5-day course of artemether-lumefantrine for treatment of uncomplicated malaria among HIV-Malaria co-infected individuals receiving efavirenz (400mg) based ART.
- To determine the safety and Pharmacokinetics of artemether-lumefantrine when administered with Dolutegravir based ART among HIV-malaria co-infected individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- A three arm single blind randomized trial. Study participants will be randomized to one of the 3 arms. Standard dose, double dose or 5 day course of Artemether-lumefantrine
| Arm | Type | Receives |
|---|---|---|
| Standard dose of Artemether lumefantrine | Experimental | Drug: Artemether-lumefantrineDose comparison-concurrent control In this arm, Participants receiving Efavirenz400mg based ART will be randomized to standard dose Artemether Lumefantrine when treating uncomplicated malaria in HIV-malaria co-infected participants |
| Double dose Artemether lumefantrine | Experimental | Drug: Artemether-lumefantrineDose comparison concurrent control In this arm, Participants receiving Efavirenz based ART will be randomized to double dose Artemether Lumefantrine when treating uncomplicated malaria in HIV-malaria co-infected participants |
| 5 day course of Artemether lumefantrine | Experimental | Drug: Artemether-lumefantrineDose comparison concurrent control In this arm, Participants receiving Efavirenz based ART will be randomized to 5 day course of Artemether Lumefantrine as opposed to the standard 3day course when treating uncomplicated malaria in HIV-malaria co-infected participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent
- Willing and able to comply with study treatment and procedures
- Age above 18 years
- Confirmed HIV positive and receiving efavirenz or dolutegravir based ART for objectives 3 and 4
- Confirmed Malaria blood film positive without evidence for severe malaria for objectives 3 and 4
Key exclusion criteria (11 listed)
- Serum alanine transaminase levels above 3x upper limit of normal
- Serum creatinine levels above 2x upper limit of normal
- Use of known inducers/inhibitors of CYP or glucuronyl transferase UGT1A1 within past 2 months (e.g. anticonvulsants, TB medications, HIV agents for prophylaxis, azole antifungals)
- 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
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 |
|---|---|---|
| Artemether-lumefantrineAlso: Efavirenz, DolutegravirA three-arm single blind Randomized Clinical Trial in which HIV-malaria co-infected individuals with uncomplicated malaria receiving efavirenz-based ART will be randomized to one of three arms; a standard dose of artemether-lumefantrine, or a double dose of artemether-lumefantrine, or a 5-day course of artemether-lumefantrine for treatment of uncomplicated malaria. Participants will be followed up for 42 days to determine safety, drug pharmacokinetics and malaria treatment outcomes. The 4th objective focuses on the interaction between Dolutegravir and Artemether Lumefantrine hence this will be a single blind pharmacokinetic trial among HIV-malaria co-infected individuals receiving Dolutegravir based ART and standard dose of artemether-lumefantrine for treatment of uncomplicated malaria. | Drug | 5 day course of Artemether lumefantrine, Double dose Artemether lumefantrine, Standard dose of Artemether lumefantrine |
Primary outcome
Measure of malaria treatment outcome adjusted by genotyping and classified as reinfection or recrudescence.
Time frame: Day 42
The Primary outcome measure will be the malaria treatment outcome adjusted by genotyping and classified as reinfection or recrudescence. Treatment outcomes will be classified on the basis of an assessment of the parasitological and clinical outcomes of antimalarial treatment according to the latest WHO guidelines. Thus, all patients will be classified as having early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response. Clinical Treatment outcomes will be assessed according to WHO criteria as; early treatment failure and late treatment failure. Parasitological treatment outcomes will be classified as late parasitological failure and adequate clinical and parasitological response.
9 secondary outcomes
Change Maximum concentration [Cmax] of the antimalarials (Artemether, dihydroartemisinin [DHA], lumefantrin and desbutylumefantrine
Time frame: over 120hours
Measuring level of Hemoglobin
Time frame: Hemoglobin will be measured from on follow-up days; 7, 14, 21 and 28.
Change in Area under the time-concentration curve [AUC] of the antimalarials (Artemether, dihydroartemisinin [DHA], lumefantrin and desbutylumefantrine
Time frame: over 120hours
Change in Time to maximum concentration [Tmax] of the antimalarials (Artemether, dihydroartemisinin [DHA], lumefantrin and desbutylumefantrine)
Time frame: over 120hours
Change in Clearance [Cl/F] of the antimalarials (Artemether, dihydroartemisinin [DHA], lumefantrin and desbutylumefantrine)
Time frame: over 120hours
Change in Trough concentration [Ctrough]) of the antimalarials (Artemether, dihydroartemisinin [DHA], lumefantrin and desbutylumefantrine)
Time frame: over 120hours
Prolongation of the QT interval
Time frame: Over 35days
Change in the level on the liver enzymes ALT and ALP
Time frame: Over 35days
Change in creatinine and urea levels
Time frame: Over 35days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Individual participant dataSharing planned: Yes
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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.
Pauline Byakika-Kibwika, PHD principal investigator
IDI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Artemether-lumefantrine in people with HIV Coinfection and Malaria, run by Makerere University at 2 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 6 inclusion and 11 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 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Pauline Byakika-Kibwika, PHD (077262688, pbyakika@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of malaria treatment outcome adjusted by genotyping and classified as reinfection or recrudescence. (time frame: Day 42). 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 6 Jan 2023.