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CompletedNCT00948896PROMOTE-ChemopUpdated Nov 24, 2015Results posted

Chemopreventive Therapy for Malaria in Ugandan Children

A Phase 3 interventional study of trimethoprim-sulfamethoxazole (TS; TMP/SMX) and sulfadoxine-pyrimethamine (SP) in Malaria, sponsored by University of California, San Francisco. Completed at 1 site in Uganda. Open to participants aged 4 Months to 5 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-24.

Sponsored by University of California, San Francisco · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
4 Months to 5 Months
Sex
All
01

Study summary

Young African children living in high transmission areas suffer the greatest burden of malaria. In most African countries, such as Uganda, the only current preventive measure against malaria in high transmission settings is the use of insecticide treated bednets (ITNs). Preliminary data show that even in the setting of ITN use, young children living in a high transmission setting suffer almost 4 episodes of clinical malaria per year, highlighting the need for new preventive strategies. Chemopreventive strategies offer a potential means of reducing the burden of malaria among young children living in a high transmission setting. This study will compare the efficacy and safety of 3 promising chemopreventive strategies (monthly dihydroartemisinin-piperaquine, monthly sulfadoxine-pyrimethamine, daily trimethoprim-sulfamethoxazole) with the current standard of no chemoprevention and will be conducted in two distinct patient populations: 1) HIV-unexposed children (HIV-uninfected children born to HIV-uninfected mothers) and 2) HIV-exposed children (HIV-uninfected children born to HIV-infected mothers). The intervention will begin in HIV-unexposed children when they reach 6 months of age, the time at which the incidence of malaria begins to increase, and will be continued until the children reach 24 months of age, which prior data suggest is when the incidence of malaria begins to decline due to the development of semi-immunity. In addition, study participants will be followed for one additional year following chemopreventive therapy to examine for "rebound" in the incidence of malaria following our intervention. HIV-exposed children will begin the intervention when they have completed breastfeeding and have been confirmed to remain HIV-uninfected. The intervention will continue until study participants reach 24 months of age and then the study participants will be followed for an additional year to examine for rebound in the incidence of malaria. It is anticipated that the results of this study will provide valuable comparative data on the effect of different chemopreventive strategies on malaria incidence in two distinct patient populations at high risk for malaria. In addition it is anticipated the results of this study will provide insight into the development of naturally acquired antimalarial immunity in the setting of chemopreventive therapy that will differ in terms of the drug regimens, the age at which the intervention is started, and the HIV status of the mothers.

Read the detailed description

Convenience sampling will be used to enroll a cohort of 600 HIV-uninfected infants between the ages of 4-5 months of age according to the following strata based on the mother's HIV status: 1) 200 HIV-exposed infants born to HIV-infected mothers, and 2) 400 HIV-unexposed infants born to HIV-uninfected mothers. Potential study participants will be identified from the Tororo District Hospital Antenatal Clinic and surrounding clinics providing routine pediatric care. Potential study participants less than 6 months of age and their parents/guardians will be referred to our study clinic for screening. Eligible children will be enrolled when they reach 4-5 months of age and followed until the age of 36 months for all their routine medical care at our designated study clinic. All mother-child pairs will receive 2 long lasting ITNs at enrollment and, as available, a basic care package including a safe water vessel, multivitamins and condoms. HIV-unexposed children will be randomized to one of four chemoprevention arms when they reach 6 months of age. All HIV-exposed children born to HIV-infected mothers will be given TS prophylaxis and mothers will be encouraged to introduce food at 6 months of life and continue breastfeeding until 1 year of life, in accordance with Ugandan Ministry of Health (MOH) guidelines. HIV-exposed children will retested for HIV approximately every 60 days during breastfeeding and 6 weeks following cessation of breastfeeding. HIV-exposed children who remain HIV-uninfected following cessation of breastfeeding will be randomized to one of four chemoprevention arms. HIV-exposed children who test positive for HIV during the course of the study (those who seroconvert during breastfeeding) will be excluded from the study and referred for appropriate care.

During the follow-up period, all patients presenting to the clinic with a new episode of fever will undergo standard evaluation (history, physical examination and Giemsa-stained blood smear) for the diagnosis of malaria. Children diagnosed with uncomplicated malaria will be treated with AL and children diagnosed with complicated malaria will be treated with quinine in accordance with national guidelines. Response to antimalarial therapy will be assessed using standardized guidelines. All AL treatment failures occurring within 14 days of diagnosis will be treated with quinine in accordance with national guidelines. In the event that a patient fails quinine therapy, therapy will be repeated with quinine plus clindamycin. Patients with complicated malaria who have contraindications to giving quinine will be treated with parenteral artesunate. All episodes diagnosed more than 14 days after a previous episode will be considered new episodes for treatment purposes. After two years of age, patients with uncomplicated malaria will have follow up visits on the days Antimalarial drugs are administered only (Day 0, 1, and 2). Routine assessments will be performed in the study clinic approximately every 30 days. Routine assessments will include review of study protocol with parents/guardians of study participants, assessment for any outside medical care, assessment for adherence to assigned chemopreventive therapy, a focused history and physical examination and routine blood smears for the detection of asymptomatic parasitemia. Routine phlebotomy will be performed approximately every 120 days for all study participants for CBC, glucose and ALT measurements.

02

Conditions studied

  • Malaria

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Keywords

  • Chemoprevention
  • Uganda
  • Malaria
  • Trimethoprim-sulfamethoxazole
  • Sulfadoxine-pyrimethamine
  • Dihydroartemisinin-piperaquine
03

In context

Malaria

1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.

This study's enrollment of 600 is above the median of 220 across 1,027 interventional studies indexed under Malaria.

Browse Malaria studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Months to 5 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Age 4 -5 months
  2. Confirmed HIV status of biological mother
  3. Negative HIV DNA PCR test at time of enrollment for infants born to HIV-infected mothers
  4. Infants born to HIV-infected mothers must be breastfeeding
  5. Residency within 30km of the study clinic
  6. Agreement to come to the study clinic for any febrile episode or other illness and avoid medications given outside the study protocol
  7. Provision of informed consent by parent/guardian

Exclusion criteria

Exclusion Criteria:

  1. History of allergy or sensitivity to TS, SP, or DP
  2. Active medical problem requiring in-patient evaluation at the time of screening
  3. Intention of moving more that 30km from the study clinic during the follow-up period
  4. Chronic medical condition (i.e. malignancy) requiring frequent medical attention
  5. Living in the same household as a previously enrolled study participant
  6. QTc interval > 450 msec
  7. Other clinically significant ECG abnormalities such as arrhythmia, ischemia, or evidence of heart failure
  8. Family history of Long QT syndrome
  9. Current use of drugs that prolong the QT interval
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
600 participants (actual)

Study arms

  • Experimental
    1

    Drug: trimethoprim-sulfamethoxazole (TS; TMP/SMX)

  • Experimental
    2

    Drug: sulfadoxine-pyrimethamine (SP)

  • Experimental
    3

    Drug: dihydroartemisinin-piperaquine (DP)

  • No intervention
    4

Interventions

  • Drugtrimethoprim-sulfamethoxazole (TS; TMP/SMX)

    daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs

  • Drugsulfadoxine-pyrimethamine (SP)

    monthly dosing given as a single dose, 500mg/25mg tabs

  • Drugdihydroartemisinin-piperaquine (DP)

    monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs

06

What researchers measure

Primary outcomes

  1. Incident Malaria Cases Per Person Year at Risk in HIV-unexposed Participants

    The incidence of malaria, defined as the number of incident episodes per time at risk, during the period the intervention was given (6-24 mo of age). Treatments within 14d of a prior episode were not considered incident events. Time at risk was from the day following the initiation of study drugs to the last day of observation, minus 14 d after each treatment for malaria.

    Time frame: 6 to 24 months of age

  2. Incident Malaria Cases Per Person Year at Risk in HIV-exposed Participants

    The primary outcome was the incidence of malaria, defined as the number of incident episodes per time at risk, during the period the intervention was given. Treatments within 14 days of a prior episode were not considered incident events. Time at risk was from the day following the initiation of study drugs to the last day of observation, minus 14 days after each treatment for malaria.

    Time frame: Randomization to 24 months of age

Secondary outcomes

  1. Incidence of Any Adverse Events Defined as Severity Grade 3-4 That Are Possibly, Probably, or Definitely Related to Study Drugs

    NIH Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events published December, 2004

    Time frame: Time from randomization until 24 months of age

  2. Rebound Incidence of Malaria Defined as the Number of Treatments for New Episodes of Malaria Per Time at Risk

    Time frame: 24 months to 36 months of age

07

Results

Posted Aug 4, 2015

Participant flow

Convenience sampling was used to enroll a cohort of 600 infants 4-5 months of age from the Tororo District Hospital Maternal and Child Health clinic between June 2010 and July 2011.

Randomization to 24 Months of Age
Participant flow — Randomization to 24 Months of Age
MilestoneHIV-unexposed & No ChemopreventionHIV-unexposed & SPHIV-unexposed & TSHIV-unexposed & DPHIV-exposed & no ChemopreventionHIV-exposed & SPHIV-exposed & TSHIV-exposed & DP
Started9898999846464747
Completed9085908744424345
Not completed8139112442
Withdrew: Death10002121
Withdrew: Withdrawal by subject35440100
Withdrew: Lost to follow-up44250010
Withdrew: Protocol violation01010011
Withdrew: Moved out of study area03310200
24 Months of Age to 36 Months of Age
Participant flow — 24 Months of Age to 36 Months of Age
MilestoneHIV-unexposed & No ChemopreventionHIV-unexposed & SPHIV-unexposed & TSHIV-unexposed & DPHIV-exposed & no ChemopreventionHIV-exposed & SPHIV-exposed & TSHIV-exposed & DP
Started9085908744424345
Completed8783858543404345
Not completed32521200
Withdrew: Death02200100
Withdrew: Withdrawal by subject10110000
Withdrew: Lost to follow-up20101000
Withdrew: Protocol violation00100100
Withdrew: Moved out of study area00010000

Outcome measures

SecondaryIncidence of Any Adverse Events Defined as Severity Grade 3-4 That Are Possibly, Probably, or Definitely Related to Study Drugs

NIH Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events published December, 2004

Time frame:
Time from randomization until 24 months of age
Reported as:
Number · incidence per person-year at risk
Incidence of Any Adverse Events Defined as Severity Grade 3-4 That Are Possibly, Probably, or Definitely Related to Study Drugs
incidence per person-year at riskHIV-unexposed & no ChemopreventionHIV-unexposed & Monthly SPHIV-unexposed & Daily TSHIV-unexposed & Monthly DPHIV-exposed & no ChemopreventionHIV-exposed & Monthly SPHIV-exposed & Daily TSHIV-exposed & Monthly DP
All grade 3-4 adverse events1.1591.4150.9140.6111.2141.4780.6590.678
Grade 3-4 AEs possibly related to study drugsNA0.0560.0540.021NA00.0620.097
All serious adverse events0.1780.3640.1960.0910.4110.4530.3300.194
Elevated Temperature0.5420.5460.3930.3230.4310.5320.2060.174
Anemia0.3840.6020.3180.1680.7050.6310.2060.291
Thrombocytopenia0.1230.1190.0610.03500.11800.058
Elevated aspartate aminotransferase0.0480.0560.0410.0210.0390.0200.0410.039
Elevated alanine aminotransferase0.0270.0280.0270.0210000
Neutropenia0.0210.0420.0140.0070000
Malnutrition00000.0200.0200.0210.039
Statistical analysis
  • HIV-unexposed & no Chemoprevention vs HIV-unexposed & Monthly DP · Negative Binomial Regression · p = <0.0001
  • HIV-unexposed & no Chemoprevention vs HIV-unexposed & Monthly DP · Negative Binomial Regression · p = <0.01 (Monthly DP arm compared to No chemoprevention arm)
  • HIV-unexposed & no Chemoprevention vs HIV-unexposed & Monthly DP · Negative Binomial Regression · p = <0.01 (Monthly DP arm compared to No chemoprevention arm)
  • HIV-unexposed & no Chemoprevention vs HIV-unexposed & Monthly DP · Negative Binomial Regression · p = <0.05 (Monthly DP arm compared to No chemoprevention arm)
  • HIV-exposed & no Chemoprevention vs HIV-exposed & Monthly DP · Negative Binomial Regression · p = <0.05 (Monthly DP arm compared with no chemoprevention arm.)
  • HIV-exposed & no Chemoprevention vs HIV-exposed & Monthly DP · Negative Binomial Regression · p = <0.05 (Monthly DP arm compared with no chemoprevention arm.)
  • HIV-exposed & no Chemoprevention vs HIV-exposed & Monthly DP · Negative Binomial Regression · p = <0.05 (Monthly DP arm compared with the no chemoprevention arm.)
  • HIV-exposed & no Chemoprevention vs HIV-exposed & Daily TS · Negative Binomial Regression · p = <0.01 (Daily TS arm compare with the no chemoprevention arm.)
SecondaryRebound Incidence of Malaria Defined as the Number of Treatments for New Episodes of Malaria Per Time at Risk
Time frame:
24 months to 36 months of age
Reported as:
Number · Incidence per person year at risk
Rebound Incidence of Malaria Defined as the Number of Treatments for New Episodes of Malaria Per Time at Risk
Incidence per person year at riskHIV-unexposed & no ChemopreventionHIV-unexposed & Monthly SPHIV-unexposed & Daily TSHIV-unexposed & Monthly DPHIV-exposed & no ChemopreventionHIV-exposed & Monthly SPHIV-exposed & Daily TSHIV-exposed & Monthly DP
All incident episodes of malaria10.8511.9810.9010.779.086.758.136.78
Complicated malaria0.0460.1320.04600.1610.1470.1160.044
All-cause hospital admissions0.0460.4520.0910.0230.4590.3180.1860.089
PrimaryIncident Malaria Cases Per Person Year at Risk in HIV-unexposed Participants

The incidence of malaria, defined as the number of incident episodes per time at risk, during the period the intervention was given (6-24 mo of age). Treatments within 14d of a prior episode were not considered incident events. Time at risk was from the day following the initiation of study drugs to the last day of observation, minus 14 d after each treatment for malaria.

Time frame:
6 to 24 months of age
Reported as:
Number · Episode per person year at risk
Incident Malaria Cases Per Person Year at Risk in HIV-unexposed Participants
Episode per person year at riskHIV-unexposed & no ChemopreventionHIV-unexposed & Monthly SPHIV-unexposed & Daily TSHIV-unexposed & Monthly DP
6-24 mo. of Age6.956.735.213.02
6-11 mo. of Age6.415.513.271.49
12-24 mo. of Age7.247.416.323.88
Statistical analysis
  • HIV-unexposed & no Chemoprevention vs HIV-unexposed & Monthly SP · Negative Binomial Regression · p = 0.57 · Protective efficacy (%): 7 · 95% CI -19 to 28The no chemoprevention arm is the reference group.
  • HIV-unexposed & no Chemoprevention vs HIV-unexposed & Daily TS · Negative Binomial Regression · p = 0.01 · Protective efficacy (%): 28 · 95% CI 7 to 44The no chemoprevention arm is the reference arm.
  • HIV-unexposed & no Chemoprevention vs HIV-unexposed & Monthly DP · Negative Binomial Regression · p = <0.001 · Protective efficacy (%): 58 · 95% CI 45 to 67The no chemoprevention arm is the reference arm.
PrimaryIncident Malaria Cases Per Person Year at Risk in HIV-exposed Participants

The primary outcome was the incidence of malaria, defined as the number of incident episodes per time at risk, during the period the intervention was given. Treatments within 14 days of a prior episode were not considered incident events. Time at risk was from the day following the initiation of study drugs to the last day of observation, minus 14 days after each treatment for malaria.

Time frame:
Randomization to 24 months of age
Reported as:
Number · Episodes per person year at risk
Incident Malaria Cases Per Person Year at Risk in HIV-exposed Participants
Episodes per person year at riskHIV-exposed & no ChemopreventionHIV-exposed & Monthly SPHIV-exposed & Daily TSHIV-exposed & Monthly DP
Randomization - 24 mo. of Age6.284.502.861.83
Randomization -16 mo. of Age5.423.721.700.90
17-24 mo. of Age7.045.223.792.67
Statistical analysis
  • HIV-exposed & no Chemoprevention vs HIV-exposed & Monthly SP · Negative Binomial Regression · p = 0.065 · Protective efficacy (%): 9 · 95% CI -35 to 38The no chemoprevention arm is the reference arm.
  • HIV-exposed & no Chemoprevention vs HIV-exposed & Daily TS · Negative Binomial Regression · p = 0.001 (Adjusted for age at randomization and incidence of malaria prior to randomization.) · Protective efficacy (%): 49 · 95% CI 23 to 66Adjusted for age at randomization and incidence of malaria prior to randomization. The no chemoprevention arm is the reference arm.
  • HIV-exposed & no Chemoprevention vs HIV-exposed & Monthly DP · Negative Binomial Regression · p = <0.001 (Adjusted for age at randomization and incidence of malaria prior to randomization.) · Protective efficacy (%): 69 · 95% CI 53 to 80Adjusted for age at randomization and incidence of malaria prior to randomization. The no chemoprevention arm is the reference arm.

Adverse events

Collected over The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
HIV-unexposed & no Chemoprevention—22/98 (22.4%)70/98 (71.4%)
HIV-unexposed & Monthly SP—25/98 (25.5%)66/98 (67.3%)
HIV-unexposed & Daily TS—20/99 (20.2%)58/99 (58.6%)
HIV-unexposed & Monthly DP—10/98 (10.2%)49/98 (50%)
HIV-exposed & no Chemoprevention—10/46 (21.7%)28/46 (60.9%)
HIV-exposed & Monthly SP—14/46 (30.4%)28/46 (60.9%)
HIV-exposed & Daily TS—10/47 (21.3%)11/47 (23.4%)
HIV-exposed & Monthly DP—8/47 (17%)14/47 (29.8%)
Most frequent serious events
Showing 10 of 16
Most frequent serious events
EventHIV-unexposed & no ChemopreventionHIV-unexposed & Monthly SPHIV-unexposed & Daily TSHIV-unexposed & Monthly DPHIV-exposed & no ChemopreventionHIV-exposed & Monthly SPHIV-exposed & Daily TSHIV-exposed & Monthly DP
AnemiaBlood and lymphatic system disorders15/9820/9814/994/988/4611/464/475/47
Elevated AST (SGOT)Hepatobiliary disorders6/980/984/993/980/460/461/470/47
Elevated ALT (SGPT)Hepatobiliary disorders5/981/981/992/980/460/461/470/47
VomitingGastrointestinal disorders0/980/980/990/980/462/460/470/47
MalnutritionMetabolism and nutrition disorders1/980/982/991/981/461/461/472/47
Elevated temperatureEndocrine disorders2/983/980/990/980/461/460/471/47
NeutropeniaBlood and lymphatic system disorders3/980/980/990/980/460/461/470/47
ThrombocytopeniaBlood and lymphatic system disorders3/983/981/990/980/460/460/470/47
DehydrationBlood and lymphatic system disorders0/980/981/992/980/461/461/470/47
Electrolyte imbalanceNervous system disorders0/980/980/990/981/460/461/471/47
Most frequent other events
Showing 10 of 14
Most frequent other events
EventHIV-unexposed & no ChemopreventionHIV-unexposed & Monthly SPHIV-unexposed & Daily TSHIV-unexposed & Monthly DPHIV-exposed & no ChemopreventionHIV-exposed & Monthly SPHIV-exposed & Daily TSHIV-exposed & Monthly DP
Elevated temperatureEndocrine disorders53/9849/9841/9932/9817/4619/469/476/47
AnemiaBlood and lymphatic system disorders31/9828/9821/9917/9814/4611/463/477/47
ThrombocytopeniaBlood and lymphatic system disorders15/987/985/995/980/465/460/473/47
Elevated AST (SGOT)Hepatobiliary disorders5/987/982/990/982/461/461/471/47
NeutropeniaBlood and lymphatic system disorders3/986/982/991/980/460/460/471/47
Elevated ALT (SGPT)Hepatobiliary disorders4/983/983/991/980/462/461/470/47
DiarrheaGastrointestinal disorders0/980/980/990/980/461/460/471/47
HyperglycemiaRenal and urinary disorders0/980/982/990/980/461/460/470/47
ChillsEndocrine disorders0/981/980/990/980/460/460/470/47
DyspneaRespiratory, thoracic and mediastinal disorders0/980/980/991/980/460/460/470/47

Baseline characteristics

Convenience sampling was used to enroll a cohort of 600 infants 4-5 mo of age from the Tororo District Hospital Maternal and Child Health Clinic between June 2010 and July 2011. The baseline characteristics were taken at enrollment.

Age, Continuous
Age, Continuous(months)HIV-unexposed & no ChemopreventionHIV-unexposed & Monthly SPHIV-unexposed & Daily TSHIV-unexposed & Monthly DPHIV-exposed & no ChemopreventionHIV-exposed & Monthly SPHIV-exposed & Daily TSHIV-exposed & Monthly DPTotal
Mean5.4 ± 0.55.3 ± 0.55.4 ± 0.55.4 ± 0.54.8 ± 0.74.7 ± 0.74.8 ± 0.84.7 ± 0.85.2 ± 0.6
Sex: Female, Male
Sex: Female, Male(Participants)HIV-unexposed & no ChemopreventionHIV-unexposed & Monthly SPHIV-unexposed & Daily TSHIV-unexposed & Monthly DPHIV-exposed & no ChemopreventionHIV-exposed & Monthly SPHIV-exposed & Daily TSHIV-exposed & Monthly DPTotal
Female4844485222212725287
Male5054514624252022292
Slept under any bednet prior night
Slept under any bednet prior night(participants)HIV-unexposed & no ChemopreventionHIV-unexposed & Monthly SPHIV-unexposed & Daily TSHIV-unexposed & Monthly DPHIV-exposed & no ChemopreventionHIV-exposed & Monthly SPHIV-exposed & Daily TSHIV-exposed & Monthly DPTotal
Yes4143404527272629278
No5755595319192118301
Slept under ITN prior night
Slept under ITN prior night(participants)HIV-unexposed & no ChemopreventionHIV-unexposed & Monthly SPHIV-unexposed & Daily TSHIV-unexposed & Monthly DPHIV-exposed & no ChemopreventionHIV-exposed & Monthly SPHIV-exposed & Daily TSHIV-exposed & Monthly DPTotal
Yes2730272922241922200
No7168726924222825379
Stunted
Stunted(participants)HIV-unexposed & no ChemopreventionHIV-unexposed & Monthly SPHIV-unexposed & Daily TSHIV-unexposed & Monthly DPHIV-exposed & no ChemopreventionHIV-exposed & Monthly SPHIV-exposed & Daily TSHIV-exposed & Monthly DPTotal
Yes101164676757
No8887939440394140522
Wasted
Wasted(participants)HIV-unexposed & no ChemopreventionHIV-unexposed & Monthly SPHIV-unexposed & Daily TSHIV-unexposed & Monthly DPHIV-exposed & no ChemopreventionHIV-exposed & Monthly SPHIV-exposed & Daily TSHIV-exposed & Monthly DPTotal
Yes4775041432
No9491929346424643547
Hemoglobin
Hemoglobin(gm/dl)HIV-unexposed & no ChemopreventionHIV-unexposed & Monthly SPHIV-unexposed & Daily TSHIV-unexposed & Monthly DPHIV-exposed & no ChemopreventionHIV-exposed & Monthly SPHIV-exposed & Daily TSHIV-exposed & Monthly DPTotal
Mean9.7 ± 1.49.6 ± 1.89.9 ± 1.59.5 ± 1.510.1 ± 1.210.0 ± 1.410.1 ± 1.110.5 ± 1.59.8 ± 1.5
Positive thick blood smear
Positive thick blood smear(participants)HIV-unexposed & no ChemopreventionHIV-unexposed & Monthly SPHIV-unexposed & Daily TSHIV-unexposed & Monthly DPHIV-exposed & no ChemopreventionHIV-exposed & Monthly SPHIV-exposed & Daily TSHIV-exposed & Monthly DPTotal
Yes222717288486120
No7671827038423941459

3 further baseline measures are reported on the registry.

08

Study locations

1 site
  • IDRC Research Clinic -Tororo District Hospital
    Tororo, Uganda
09

References and documents

Publications

  • Osterbauer B, Kapisi J, Bigira V, Mwangwa F, Kinara S, Kamya MR, Dorsey G. Factors associated with malaria parasitaemia, malnutrition, and anaemia among HIV-exposed and unexposed Ugandan infants: a cross-sectional survey. Malar J. 2012 Dec 27;11:432. doi: 10.1186/1475-2875-11-432. PubMed 23270614 ↗
  • Ochong E, Tumwebaze PK, Byaruhanga O, Greenhouse B, Rosenthal PJ. Fitness Consequences of Plasmodium falciparum pfmdr1 Polymorphisms Inferred from Ex Vivo Culture of Ugandan Parasites. Antimicrob Agents Chemother. 2013 Sep;57(9):4245-4251. doi: 10.1128/AAC.00161-13. Epub 2013 Jun 24. PubMed 23796921 ↗
  • Marquez C, Okiring J, Chamie G, Ruel TD, Achan J, Kakuru A, Kamya MR, Charlebois ED, Havlir DV, Dorsey G. Increased morbidity in early childhood among HIV-exposed uninfected children in Uganda is associated with breastfeeding duration. J Trop Pediatr. 2014 Dec;60(6):434-41. doi: 10.1093/tropej/fmu045. Epub 2014 Aug 21. PubMed 25145704 ↗
  • Kamya MR, Kapisi J, Bigira V, Clark TD, Kinara S, Mwangwa F, Muhindo MK, Kakuru A, Aweeka FT, Huang L, Jagannathan P, Achan J, Havlir DV, Rosenthal PJ, Dorsey G. Efficacy and safety of three regimens for the prevention of malaria in young HIV-exposed Ugandan children: a randomized controlled trial. AIDS. 2014 Nov 28;28(18):2701-9. doi: 10.1097/QAD.0000000000000497. PubMed 25493596 ↗
  • Kapisi J, Bigira V, Clark T, Kinara S, Mwangwa F, Achan J, Kamya M, Soremekun S, Dorsey G. Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated malaria in the setting of three different chemopreventive regimens. Malar J. 2015 Feb 5;14:53. doi: 10.1186/s12936-015-0583-9. PubMed 25652127 ↗
  • Snyman K, Mwangwa F, Bigira V, Kapisi J, Clark TD, Osterbauer B, Greenhouse B, Sturrock H, Gosling R, Liu J, Dorsey G. Poor housing construction associated with increased malaria incidence in a cohort of young Ugandan children. Am J Trop Med Hyg. 2015 Jun;92(6):1207-13. doi: 10.4269/ajtmh.14-0828. Epub 2015 Apr 13. PubMed 25870429 ↗
  • Bigira V, Kapisi J, Clark TD, Kinara S, Mwangwa F, Muhindo MK, Osterbauer B, Aweeka FT, Huang L, Achan J, Havlir DV, Rosenthal PJ, Kamya MR, Dorsey G. Protective efficacy and safety of three antimalarial regimens for the prevention of malaria in young Ugandan children: a randomized controlled trial. PLoS Med. 2014 Aug 5;11(8):e1001689. doi: 10.1371/journal.pmed.1001689. eCollection 2014 Aug. PubMed 25093754 ↗
  • Sundell K, Jagannathan P, Huang L, Bigira V, Kapisi J, Kakuru MM, Savic R, Kamya MR, Dorsey G, Aweeka F. Variable piperaquine exposure significantly impacts protective efficacy of monthly dihydroartemisinin-piperaquine for the prevention of malaria in Ugandan children. Malar J. 2015 Sep 24;14:368. doi: 10.1186/s12936-015-0908-8. PubMed 26403465 ↗
  • Tumwebaze P, Conrad MD, Walakira A, LeClair N, Byaruhanga O, Nakazibwe C, Kozak B, Bloome J, Okiring J, Kakuru A, Bigira V, Kapisi J, Legac J, Gut J, Cooper RA, Kamya MR, Havlir DV, Dorsey G, Greenhouse B, Nsobya SL, Rosenthal PJ. Impact of antimalarial treatment and chemoprevention on the drug sensitivity of malaria parasites isolated from ugandan children. Antimicrob Agents Chemother. 2015;59(6):3018-30. doi: 10.1128/AAC.05141-14. Epub 2015 Mar 9. PubMed 25753626 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00948896
Lead sponsor
University of California, San Francisco
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Grant Dorsey, M.D, Ph.D. (Associate Professor, University of California, San Francisco) — Principal investigator
First posted
Jul 29, 2009
Start date
Jun 2010
Primary completion
Apr 2014
Completion
Apr 2014
Results posted
Aug 4, 2015
Last update
Nov 24, 2015

Study contacts

Diane V. Havlir, MD
study director · University of California, San Francisco
M. Grant Dorsey, MD, PhD
principal investigator · University of California, San Francisco
Moses R Kamya MBChB, MMed, MPH
principal investigator · Makerere University; IDRC

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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