MalariaNCT01717885
Antimalarial Pharmacology in Children and Pregnant Women in Uganda
An observational study of Malaria and HIV, run by University of California, San Francisco at 1 site in Uganda.
Trial summary
The burden of malaria is greatest in children and pregnant women in sub-Saharan Africa. Malaria is one of the most important infectious diseases in the world. Uganda reports among the highest transmission intensities in the world. Children and pregnant women are the most vulnerable populations. Read more about this study
- Who is it for?
- Ages 6 months and older
- How many people
- 473 participants
- Where
- 1 siteUganda
- Study dates
- Aug 2012to Sep 2016
- Phase
- Observational
- 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 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: HIV infected and uninfected children and pregnant women residing in Tororo, Uganda and receiving care at local health care facilities including the Tororo District Hospital (TDH), perinatal facilities, HIV clinics and the IDRC research clinic. HIV uninfected children, pregnant women and non-pregnant adults also enrolled through TDH, perinatal facilities or other area clinics. Each participant can enroll at the time they present to one of the clinics with uncomplicated malaria
Who may be able to join
- ALL PARTICIPANTS
- Residency within 60 km of the study clinic
- Agreement to come to clinic for all follow-up clinical and PK evaluations
- Provision of informed consent
- HIV-INFECTED PARTICIPANTS
- Children:
Show all 44Show fewer
- 1) Enrollment in Promote I or meets enrollment criteria and recruited from TDH/TASO or other referral site
- 6 months to 8 years of age
- Weight ≥6 kg
- Confirmed HIV infection (positive rapid HIV test to be confirmed by Western Blot or HIV RNA after enrollment)
- On a stable ART regimen for at least 10 days prior to enrollment
- If co-enrolled from PROMOTE, willingness to undergo intensive PK sampling during a single episode of uncomplicated malaria, and/or population PK/parasite clearance time studies during multiple episodes of uncomplicated malaria.
- If enrolled from TDH, willingness to undergo intensive PK sampling during a single episode of malaria or population PK/parasite clearance time studies during episodes of uncomplicated malaria.
- Pregnant women
- Enrollment in Promote Project 2 or meets enrollment criteria and recruited from TDH/TASO or other referral site
- On a stable ART regimen for at least 10 days prior to enrollment
- Presentation with uncomplicated malaria at the time of enrollment
- Confirmed pregnancy (apparent pregnancy, positive pregnancy test or pregnancy by ultrasound)
- Confirmed HIV infection (positive rapid HIV test to be confirmed by Western Blot or HIV RNA after enrollment)
- 16 years of age or older
- Estimated gestational age between 12 and 38 weeks by last menstrual period and report of quickening
- Willingness to undergo intensive PK sampling during episodes of uncomplicated malaria during pregnancy.
- HIV UNINFECTED PARTICIPANTS
- Children:
- Enrollment from TDH or other referral site
- 6 months to 8 years of age
- Weight ≥6 kg
- Confirmed HIV negative test (negative rapid HIV test to be confirmed by Western Blot or HIV RNA after enrollment)
- Presentation with uncomplicated falciparum malaria as indicated by positive smear for malaria parasites along with clinical evidence of infection (fever or history of fever in the past 24 hours) with planned treatment with AL.
- 7) Willingness to undergo intensive PK sampling during a single episode of malaria or population PK/parasite clearance time studies during episodes of uncomplicated malaria.
- Non-pregnant adults:
- Age ≥ 16 years
- Confirmed HIV negative test (negative rapid HIV test to be confirmed by Western Blot or HIV RNA after enrollment).
- Presentation with uncomplicated falciparum malaria as indicated by positive smear for malaria parasites along with clinical evidence of infection (fever or history of fever in the past 24 hours) with planned treatment with AL.
- Negative pregnancy test
- Willingness to undergo intensive PK sampling during treatment for a single episode of uncomplicated malaria
- Pregnant women:
- Age ≥ 16 years
- Confirmed HIV negative test (negative rapid HIV test to be confirmed by Western Blot or HIV RNA after enrollment)
- Confirmed pregnancy (apparent pregnancy, positive pregnancy test or pregnancy by ultrasound)
- Estimated gestational age between 12 and 38 weeks by last menstrual period and report of quickening
- Presentation with uncomplicated malaria as indicated by positive smear for malaria parasites along with clinical evidence of infection (fever or history of fever in the past 24 hours) with planned treatment with AL.
- No evidence of imminent delivery or threatened abortion at the time of presentation with malaria.
- Willingness to undergo intensive PK sampling during episodes of uncomplicated malaria during pregnancy.
Who cannot join
- History of significant comorbidities such as malignancy, active tuberculosis or other WHO stage 4 disease
- Current infection with non-falciparum species
- Receipt of any medications known to affect cytochrome p450 (CYP450) metabolism (except ART) within 14 days of study enrollment (see 4.2.2)
- Hemoglobin < 7.0 g/dL
- Prior treatment for malaria within 14 days of study enrollment (intensive PK study participants only)
- Signs or evidence of complicated malaria, defined as unarousable coma OR ANY TWO OF THE FOLLOWING SYMPTOMS: Recent febrile convulsions, altered consciousness, lethargy, unable to drink, unable to stand/sit due to weakness, severe anemia (Hb < 5.0 gm/dL), respiratory distress, jaundice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antimalarial Pharmacology in HIV Infected and Uninfected Children and Pregnant Women in Uganda
The burden of malaria is greatest in children and pregnant women in sub-Saharan Africa. Malaria is one of the most important infectious diseases in the world. Uganda reports among the highest transmission intensities in the world. Children and pregnant women are the most vulnerable populations. HIV is also reported at high rates for these populations. If malaria and HIV require treatment at the same time, there is a high risk for drug-drug interactions. This study will:
- Determine if the use of anti-HIV medications including lopinavir/ritonavir (LPV/r), nevirapine (NVP) and efavirenz (EFV) will affect the pharmacokinetic (PK) exposure of antimalarial medications (specifically artemether-lumefantrine, AL) during the treatment for uncomplicated malaria in HIV-infected children and pregnant women, and
- Evaluate the impact of age and pregnancy on the PK exposure of AL.
Read the detailed description
This study is designed to directly address antimalarial PK and pharmacodynamics (PD) objectives in children and pregnant women, the populations most vulnerable to malaria. This study will focus on the pharmacology of artemether-lumefantrine (AL), the most commonly prescribed anti-malarial drug in sub-Saharan Africa and inform specific dosing guidelines for AL treatment of uncomplicated malaria for these populations. Traditionally, studies have focused on non-pregnant adults, largely ignoring the effects of childhood maturation and pregnancy on drug disposition. This gap in research is specified as a top priority by the WorldWide Antimalarial Resistance Network (WWARN), who emphasize the importance of proper PK and PD study in relevant populations to reduce the threat of ACT drug resistance and treatment failure. This study will allow optimization of ACT regimens, especially in the setting of HIV co-infection and inform use of ART, specifically for the nucleoside analogues, in the setting of malaria and ACT, with the goal of reducing toxicity.
This study complements ongoing PROMOTE trials and provides valuable PK and PD data leveraged to the existing trials, greatly decreasing research costs. This study involves co-enrollment of HIV-infected children and pregnant women already enrolled in PROMOTE which is investigating PI- vs NNRTI-based ART treatment strategies for reducing malaria-related morbidity in HIV and malaria co-infected children and pregnant women. PROMOTE trials were designed in collaboration with Ugandan health care experts and officials and results are expected to rapidly impact Ugandan health policy. This study builds on knowledge gained through PROMOTE. The study also permits enrollment of HIV infected children and pregnant women not in PROMOTE but managed through TDH or other referral site in the Tororo area. Lastly this study will enroll HIV uninfected children, pregnant women and non-pregnant adults.
This study utilizes state-of-the-art PK designs and drug assay methods relying on a combination of intensive and population models to optimize PK/PD analysis. Intensive studies using serial sampling in a relatively small number of subjects will address focused questions on PK exposure while population studies using less frequent sampling in large numbers of subjects will study relationships between PK exposure, clinical response (treatment failure, new infection, and placental malaria), and toxicity (neutropenia) while considering multiple potential covariates. This study includes development and utilization of small volume assay methods for ACT and ART to optimize PK/PD study in children and pregnant women and will be a useful tool for future research trials in resource limited settings.
Rationale for this study is summarized below:
- Dosing guidelines for children and pregnant women have relied on studies carried out in non-pregnant adults
- Children and pregnant women exhibit distinct physiological characteristics that impact how drugs are handled by the body and thus are likely treated improperly
- This gap in research has been deemed an area of high priority by WWARN • Improper dosing may compromise care of acute infection but more importantly contribute to develop of resistance
- ACT therapies must be protected from factors contributing to resistance
- Drug-drug interactions between anti-malarial treatment and ART must be evaluated to assure optimized dosing.
- Drug toxicity, in particular neutropenia, in the setting of HIV-malaria co-infection may be due to important drug-drug interactions
- Intensive PK design resulting in determination of a precise area under the concentration versus time curve (AUC) will permit robust comparisons so that results will inform treatment guidelines and policy for HIV-infected children and pregnant women.
- Once optimized dosing is determined, the PK of this new dosing will be confirmed through follow-up (F/U) studies
- We need state of the art analytical tools to quantitate key drugs in small volume samples collected from vulnerable populations including young children
- Keywords
- Pharmacokinetics, Antimalarial, HIV, Antiretrovirals, Childhood development, Pregnancy
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV+children on LPV/r | HIV+ children who are stabilized on a LPV/r based ART regimen | |
| HIV+ children on nevirapine | HIV+ children who are stabilized on an nevirapine based ART regimen | |
| HIV+ children on efavirenz | HIV+ children who are stabilized on an efavirenz based ART regimen | |
| HIV+ pregnant women on LPV/r | HIV+ pregnant women who are stabilized on an LPV/r based ART regimen | |
| HIV+ pregnant women on NVP | HIV+ pregnant women who are stabilized on an nevirapine based ART regimen | |
| HIV+ pregnant women on EFV | HIV+ pregnant women stabilized on an efavirenz based ART regimen | |
| HIV negative children | HIV negative children that will serve as a control for HIV positive children on either a LPV/r, NVP or EFV based ART regimen and will be compared to HIV negative non-pregnant adults | |
| HIV negative adults | HIV negative adults that will serve as a control for comparing results to HIV negative children and HIV negative pregnant women | |
| HIV negative pregnant women | HIV negative pregnant women who will serve as a control for HIV positive pregnant women on either a LPV/r, NVP or EFV based ART regimen and will be compared to HIV negative non-pregnant adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measurement is the area under the plasma concentration versus time curve for all drug analytes.
Pharmacokinetic exposure for the antimalarial medication is estimated through sparse or intensive blood sampling around the last dose and for several days following the last dose.
Measured: At time of the last dose of a 6 dose regimen and up to 42 days of F/U
Secondary outcomes (3)
Malaria reinfection (recrudescence or new infection)
The association between PK exposure and malaria reinfection is the main secondary outcome.
Measured: From Day 0 to 42 days of F/U when using artemether-lumefantrine for uncomplicated malaria
Parasite clearance rate
To assess the relationship between artemisinin exposure and parasite clearance
Measured: Days 0 to 42 of follow-up
AL and ART toxicity
To assess the relationship between artemether, lumefantrine and antiretroviral exposure and toxicity, particularly neutropenia
Measured: Days 0 to 42 of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 473 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Francesca T Aweeka, Pharm.D., Study director, University of California, San FranciscoSunil Parikh, MD MPH, Principal investigator, Yale UniversityNorah Mwebaza, MBChB, MSc, Principal investigator, Makerere UniversityMyaing Nyunt, MD PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717885
- Sponsor's protocol ID
- 10-04798
- Other IDs
- R01HD068174
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2012
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Nyunt MM, Nguyen VK, Kajubi R, Huang L, Ssebuliba J, Kiconco S, Mwima MW, Achan J, Aweeka F, Parikh S, Mwebaza N. Artemether-Lumefantrine Pharmacokinetics and Clinical Response Are Minimally Altered in Pregnant Ugandan Women Treated for Uncomplicated Falciparum Malaria. Antimicrob Agents Chemother. 2015 Dec 14;60(3):1274-82. doi: 10.1128/AAC.01605-15.
PubMed 26666942Parikh S, Kajubi R, Huang L, Ssebuliba J, Kiconco S, Gao Q, Li F, Were M, Kakuru A, Achan J, Mwebaza N, Aweeka FT. Antiretroviral Choice for HIV Impacts Antimalarial Exposure and Treatment Outcomes in Ugandan Children. Clin Infect Dis. 2016 Aug 1;63(3):414-22. doi: 10.1093/cid/ciw291. Epub 2016 May 3.
PubMed 27143666Kajubi R, Huang L, Were M, Kiconco S, Li F, Marzan F, Gingrich D, Nyunt MM, Ssebuliba J, Mwebaza N, Aweeka FT, Parikh S. Parasite Clearance and Artemether Pharmacokinetics Parameters Over the Course of Artemether-Lumefantrine Treatment for Malaria in Human Immunodeficiency Virus (HIV)-Infected and HIV-Uninfected Ugandan Children. Open Forum Infect Dis. 2016 Dec 15;3(4):ofw217. doi: 10.1093/ofid/ofw217. eCollection 2016 Oct.
PubMed 28018925Lehane A, Were M, Wade M, Hamadu M, Cahill M, Kiconco S, Kajubi R, Aweeka F, Mwebaza N, Li F, Parikh S. Comparison on simultaneous caillary and venous parasite density and genotyping results from children and adults with uncomplicated malaria: a prospective observational study in Uganda. BMC Infect Dis. 2019 Jun 26;19(1):559. doi: 10.1186/s12879-019-4174-1.
PubMed 31242863
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimalarial Pharmacology in HIV Infected and Uninfected Children and Pregnant Women in Uganda
- ClinicalTrials.gov ID
- NCT01717885
- Acronym / sponsor ID
- 10-04798
- Keywords
- Pharmacokinetics, Antimalarial, HIV, Antiretrovirals, Childhood development, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 473 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Aug 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 31 Oct 2012 (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.
The burden of malaria is greatest in children and pregnant women in sub-Saharan Africa. Malaria is one of the most important infectious diseases in the world. Uganda reports among the highest transmission intensities in the world. Children and pregnant women are the most vulnerable populations. HIV is also reported at high rates for these populations. If malaria and HIV require treatment at the same time, there is a high risk for drug-drug interactions. This study will:
- Determine if the use of anti-HIV medications including lopinavir/ritonavir (LPV/r), nevirapine (NVP) and efavirenz (EFV) will affect the pharmacokinetic (PK) exposure of antimalarial medications (specifically artemether-lumefantrine, AL) during the treatment for uncomplicated malaria in HIV-infected children and pregnant women, and
- Evaluate the impact of age and pregnancy on the PK exposure of AL.
Detailed description
This study is designed to directly address antimalarial PK and pharmacodynamics (PD) objectives in children and pregnant women, the populations most vulnerable to malaria. This study will focus on the pharmacology of artemether-lumefantrine (AL), the most commonly prescribed anti-malarial drug in sub-Saharan Africa and inform specific dosing guidelines for AL treatment of uncomplicated malaria for these populations. Traditionally, studies have focused on non-pregnant adults, largely ignoring the effects of childhood maturation and pregnancy on drug disposition. This gap in research is specified as a top priority by the WorldWide Antimalarial Resistance Network (WWARN), who emphasize the importance of proper PK and PD study in relevant populations to reduce the threat of ACT drug resistance and treatment failure. This study will allow optimization of ACT regimens, especially in the setting of HIV co-infection and inform use of ART, specifically for the nucleoside analogues, in the setting of malaria and ACT, with the goal of reducing toxicity.
This study complements ongoing PROMOTE trials and provides valuable PK and PD data leveraged to the existing trials, greatly decreasing research costs. This study involves co-enrollment of HIV-infected children and pregnant women already enrolled in PROMOTE which is investigating PI- vs NNRTI-based ART treatment strategies for reducing malaria-related morbidity in HIV and malaria co-infected children and pregnant women. PROMOTE trials were designed in collaboration with Ugandan health care experts and officials and results are expected to rapidly impact Ugandan health policy. This study builds on knowledge gained through PROMOTE. The study also permits enrollment of HIV infected children and pregnant women not in PROMOTE but managed through TDH or other referral site in the Tororo area. Lastly this study will enroll HIV uninfected children, pregnant women and non-pregnant adults.
This study utilizes state-of-the-art PK designs and drug assay methods relying on a combination of intensive and population models to optimize PK/PD analysis. Intensive studies using serial sampling in a relatively small number of subjects will address focused questions on PK exposure while population studies using less frequent sampling in large numbers of subjects will study relationships between PK exposure, clinical response (treatment failure, new infection, and placental malaria), and toxicity (neutropenia) while considering multiple potential covariates. This study includes development and utilization of small volume assay methods for ACT and ART to optimize PK/PD study in children and pregnant women and will be a useful tool for future research trials in resource limited settings.
Rationale for this study is summarized below:
- Dosing guidelines for children and pregnant women have relied on studies carried out in non-pregnant adults
- Children and pregnant women exhibit distinct physiological characteristics that impact how drugs are handled by the body and thus are likely treated improperly
- This gap in research has been deemed an area of high priority by WWARN • Improper dosing may compromise care of acute infection but more importantly contribute to develop of resistance
- ACT therapies must be protected from factors contributing to resistance
- Drug-drug interactions between anti-malarial treatment and ART must be evaluated to assure optimized dosing.
- Drug toxicity, in particular neutropenia, in the setting of HIV-malaria co-infection may be due to important drug-drug interactions
- Intensive PK design resulting in determination of a precise area under the concentration versus time curve (AUC) will permit robust comparisons so that results will inform treatment guidelines and policy for HIV-infected children and pregnant women.
- Once optimized dosing is determined, the PK of this new dosing will be confirmed through follow-up (F/U) studies
- We need state of the art analytical tools to quantitate key drugs in small volume samples collected from vulnerable populations including young children
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| HIV+children on LPV/r | – | –HIV+ children who are stabilized on a LPV/r based ART regimen |
| HIV+ children on nevirapine | – | –HIV+ children who are stabilized on an nevirapine based ART regimen |
| HIV+ children on efavirenz | – | –HIV+ children who are stabilized on an efavirenz based ART regimen |
| HIV+ pregnant women on LPV/r | – | –HIV+ pregnant women who are stabilized on an LPV/r based ART regimen |
| HIV+ pregnant women on NVP | – | –HIV+ pregnant women who are stabilized on an nevirapine based ART regimen |
| HIV+ pregnant women on EFV | – | –HIV+ pregnant women stabilized on an efavirenz based ART regimen |
| HIV negative children | – | –HIV negative children that will serve as a control for HIV positive children on either a LPV/r, NVP or EFV based ART regimen and will be compared to HIV negative non-pregnant adults |
| HIV negative adults | – | –HIV negative adults that will serve as a control for comparing results to HIV negative children and HIV negative pregnant women |
| HIV negative pregnant women | – | –HIV negative pregnant women who will serve as a control for HIV positive pregnant women on either a LPV/r, NVP or EFV based ART regimen and will be compared to HIV negative non-pregnant adults |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- HIV infected and uninfected children and pregnant women residing in Tororo, Uganda and receiving care at local health care facilities including the Tororo District Hospital (TDH), perinatal facilities, HIV clinics and the IDRC research clinic. HIV uninfected children, pregnant women and non-pregnant adults also enrolled through TDH, perinatal facilities or other area clinics. Each participant can enroll at the time they present to one of the clinics with uncomplicated malaria
Key inclusion criteria (44 listed)
- ALL PARTICIPANTS
- Residency within 60 km of the study clinic
- Agreement to come to clinic for all follow-up clinical and PK evaluations
- Provision of informed consent
- HIV-INFECTED PARTICIPANTS
Key exclusion criteria (6 listed)
- History of significant comorbidities such as malignancy, active tuberculosis or other WHO stage 4 disease
- Current infection with non-falciparum species
- Receipt of any medications known to affect cytochrome p450 (CYP450) metabolism (except ART) within 14 days of study enrollment (see 4.2.2)
- Hemoglobin < 7.0 g/dL
- Prior treatment for malaria within 14 days of study enrollment (intensive PK study participants only)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary outcome measurement is the area under the plasma concentration versus time curve for all drug analytes.
Time frame: At time of the last dose of a 6 dose regimen and up to 42 days of F/U
Pharmacokinetic exposure for the antimalarial medication is estimated through sparse or intensive blood sampling around the last dose and for several days following the last dose.
3 secondary outcomes
Malaria reinfection (recrudescence or new infection)
Time frame: From Day 0 to 42 days of F/U when using artemether-lumefantrine for uncomplicated malaria
Parasite clearance rate
Time frame: Days 0 to 42 of follow-up
AL and ART toxicity
Time frame: Days 0 to 42 of follow-up
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 24 Oct 2024.
- Results publication: PubMed 26666942Nyunt MM, Nguyen VK, Kajubi R, Huang L, Ssebuliba J, Kiconco S, Mwima MW, Achan J, Aweeka F, Parikh S, Mwebaza N. Artemether-Lumefantrine Pharmacokinetics and Clinical Response Are Minimally Altered in Pregnant Ugandan Women Treated for Uncomplicated Falciparum Malaria. Antimicrob Agents Chemother. 2015 Dec 14;60(3):1274-82. doi: 10.1128/AAC.01605-15.
- Results publication: PubMed 27143666Parikh S, Kajubi R, Huang L, Ssebuliba J, Kiconco S, Gao Q, Li F, Were M, Kakuru A, Achan J, Mwebaza N, Aweeka FT. Antiretroviral Choice for HIV Impacts Antimalarial Exposure and Treatment Outcomes in Ugandan Children. Clin Infect Dis. 2016 Aug 1;63(3):414-22. doi: 10.1093/cid/ciw291. Epub 2016 May 3.
- Results publication: PubMed 28018925Kajubi R, Huang L, Were M, Kiconco S, Li F, Marzan F, Gingrich D, Nyunt MM, Ssebuliba J, Mwebaza N, Aweeka FT, Parikh S. Parasite Clearance and Artemether Pharmacokinetics Parameters Over the Course of Artemether-Lumefantrine Treatment for Malaria in Human Immunodeficiency Virus (HIV)-Infected and HIV-Uninfected Ugandan Children. Open Forum Infect Dis. 2016 Dec 15;3(4):ofw217. doi: 10.1093/ofid/ofw217. eCollection 2016 Oct.
- Derived from this study: PubMed 31242863Lehane A, Were M, Wade M, Hamadu M, Cahill M, Kiconco S, Kajubi R, Aweeka F, Mwebaza N, Li F, Parikh S. Comparison on simultaneous caillary and venous parasite density and genotyping results from children and adults with uncomplicated malaria: a prospective observational study in Uganda. BMC Infect Dis. 2019 Jun 26;19(1):559. doi: 10.1186/s12879-019-4174-1.
- 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.
Francesca T Aweeka, Pharm.D. study director
University of California, San Francisco
Sunil Parikh, MD MPH principal investigator
Yale University
Norah Mwebaza, MBChB, MSc principal investigator
Makerere University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria and HIV, run by University of California, San Francisco 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 44 inclusion and 6 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 24 Oct 2024. 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.
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?
Primary outcome measurement is the area under the plasma concentration versus time curve for all drug analytes. (time frame: At time of the last dose of a 6 dose regimen and up to 42 days of F/U). 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 NCT01717885, which also lists 4 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 24 Oct 2024.