ClinicalTrials.gov
ClinicalTrials.gov Menu

HIV Protease Inhibitors for the Prevention of Malaria in Ugandan Children (PROMOTE-PEDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00978068
Recruitment Status : Completed
First Posted : September 16, 2009
Results First Posted : December 28, 2018
Last Update Posted : December 28, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Malaria
HIV Infections
Interventions Drug: Lopinavir/Ritonavir (LPV/r)
Drug: Nevirapine (NVP)
Drug: Efavirenz (EFV)
Drug: 2 nucleoside reverse transcriptase inhibitor (NRTI)
Enrollment 176
Recruitment Details Children were recruited from September 2009 through July 2011.
Pre-assignment Details

A total of 404 children were screened for eligibility; 228 were found not to be eligible. The main reasons for ineligibility were:

136 Were not eligible for ART 34 Were on ART with detectable viral load 32 Were HIV- 8 Had not received ART but had prior exposure to nevirapine

Arm/Group Title LPV/r + 2 NRTIs NVP or EFV + 2 NRTIs
Hide Arm/Group Description

LPV/r + 2 NRTIs: Group 1

Lopinavir/ritonavir (LPV/r) +2 nucleoside reverse transcriptase inhibitor (NRTI)

The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin < 8 gm/dL, in which case it will be Abacavir. Stavudine will be used in the event that a participant is unable to take Abacavir for safety or other reasons.

NVP or EFV + 2 NRTIs: Group 2

Nevirapine (NVP) or Efavirenz (EFV) + 2 NRTI

NVP will be used for children < 3 years of age and EFV for children ≥3 years of age. The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin < 8 gm/dL, in which case it will be stavudine.

Period Title: Overall Study
Started 87 89
Initiated Study Drugs 84 86
Completed 83 80
Not Completed 4 9
Reason Not Completed
Were Awaiting Initiation of ART             2             2
Death             1             2
Lost to Follow-up             1             2
Physician Decision             0             1
Unable to Comply with Study             0             2
Arm/Group Title LPV/r + 2 NRTIs NVP or EFV + 2 NRTIs Total
Hide Arm/Group Description

LPV/r + 2 NRTIs: Group 1

Lopinavir/ritonavir (LPV/r) +2 nucleoside reverse transcriptase inhibitor (NRTI)

The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin < 8 gm/dL, in which case it will be Abacavir. Stavudine will be used in the event that a participant is unable to take Abacavir for safety or other reasons.

NVP or EFV + 2 NRTIs: Group 2

Nevirapine (NVP) or Efavirenz (EFV) + 2 NRTI

NVP will be used for children < 3 years of age and EFV for children ≥3 years of age. The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin < 8 gm/dL, in which case it will be stavudine.

Total of all reporting groups
Overall Number of Baseline Participants 84 86 170
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 84 participants 86 participants 170 participants
2.9
(0.7 to 6.0)
3.1
(0.5 to 5.9)
3.1
(0.5 to 6.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 86 participants 170 participants
Female
41
  48.8%
41
  47.7%
82
  48.2%
Male
43
  51.2%
45
  52.3%
88
  51.8%
Previous ART to Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 84 participants 86 participants 170 participants
No Previous ART 57 58 115
Previous ART 27 28 55
WHO Clinical HIV stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 84 participants 86 participants 170 participants
Stage I (Asymptomatic) 60 66 126
Stage II (mod. unexplained weight loss) 16 15 31
Stage III (unexplained severe weight loss) 2 1 3
Stage IV (HIV wasting syndrome) 6 4 10
[1]
Measure Description: clinical staging is based on standard WHO grading scales found is the document: https://www.who.int/hiv/pub/guidelines/clinicalstaging.pdf
CD4 Percentage   [1] 
Median (Full Range)
Unit of measure:  % of white cells that are CD4 cells
Number Analyzed 84 participants 86 participants 170 participants
No Previous ART
14
(2 to 44)
16
(2 to 43)
16
(2 to 44)
Previous ART
31
(8 to 51)
30
(10 to 45)
30
(8 to 51)
[1]
Measure Description: The percentage represents the percentage of white cells that are CD4 cells.
Viral Load   [1] 
Median (Full Range)
Unit of measure:  log10copies/mL
Number Analyzed 84 participants 86 participants 170 participants
No Previous ART
5.4
(0 to 6.4)
5.5
(0 to 6.4)
5.5
(0 to 6.4)
Previous ART
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
[1]
Measure Description: 0 = below the level of detection (<400 copies per microliter).
[2]
Below the level of detection (<400 copies per microliter)
Hemoglobin  
Mean (Standard Deviation)
Unit of measure:  g/dL
Number Analyzed 84 participants 86 participants 170 participants
10.4  (1.3) 10.6  (1.5) 10.5  (1.4)
Result of Baseline Blood Smear for Asexual Parasites  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 84 participants 86 participants 170 participants
Positive 10 11 21
Negative 74 75 149
1.Primary Outcome
Title Incidence-density of Malaria Defined as the Number of Incident Episodes of Malaria Per Time at Risk.
Hide Description [Not Specified]
Time Frame Time from randomization to at least 24 months of follow up or until end of the study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1: LPV/r + 2 NRTIs Group 2: Nevirapine (NVP) or Efavirenz (EFV) + 2 NRTIs
Hide Arm/Group Description:

Lopinavir/ritonavir (LPV/r) +2 nucleoside reverse transcriptase inhibitor (NRTI)

The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin < 8 gm/dL, in which case it will be Abacavir. Stavudine will be used in the event that a participant is unable to take Abacavir for safety or other reasons.

NVP will be used for children < 3 years of age and EFV for children ≥3 years of age. The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin < 8 gm/dL, in which case it will be stavudine.
Overall Number of Participants Analyzed 84 86
Measure Type: Number
Unit of Measure: Episodes/ Person-Yr at Risk
1.32 2.25
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: LPV/r + 2 NRTIs, Group 2: Nevirapine (NVP) or Efavirenz (EFV) + 2 NRTIs
Comments We assumed that the incidence of malaria in Group 2 would be 0.70 episodes per person-year and estimated that we would need a sample of 300 participants for the study to have 80% power to show a 35% reduction in the incidence of malaria in Group 1, at a 2-sided significance level of 0.05. We then observed an incidence of malaria in Group 2 that was higher than anticipated (2.19 episodes/person-yr) and revised the sample size to 150 participants, who would be followed for at least 6 months.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Negative Binomial Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence Rate Ratio
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
0.36 to 0.97
Estimation Comments Group 1 represents the numerator for the rate ratio. Group 2 represents the denominator for the rate ratio.
2.Secondary Outcome
Title Percentage of Uncomplicated Malaria Episodes With Accompanying Adverse Events That Occurred in the 28 Days Following Antimalarial Therapy
Hide Description The rates of adverse events, defined as severity grade 2 or higher that are possibly, probably or definitely related to study drugs over the course of the 28-day period after antimalarial therapy with artemether–lumefantrine (AL).
Time Frame 28 days after antimalarial therapy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LPV/r + 2 NRTIs NVP or EFV + 2 NRTIs
Hide Arm/Group Description:

LPV/r + 2 NRTIs: Group 1

Lopinavir/ritonavir (LPV/r) +2 nucleoside reverse transcriptase inhibitor (NRTI)

The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin < 8 gm/dL, in which case it will be Abacavir. Stavudine will be used in the event that a participant is unable to take Abacavir for safety or other reasons.

NVP or EFV + 2 NRTIs: Group 2

Nevirapine (NVP) or Efavirenz (EFV) + 2 NRTI

NVP will be used for children < 3 years of age and EFV for children ≥3 years of age. The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin < 8 gm/dL, in which case it will be stavudine.

Overall Number of Participants Analyzed 84 86
Measure Type: Number
Unit of Measure: % uncomplicated malaria episodes w/ AEs
71.0 79.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LPV/r + 2 NRTIs, NVP or EFV + 2 NRTIs
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Cox Proportional-Hazards
Comments [Not Specified]
3.Secondary Outcome
Title Incidence-density of Malaria Defined as the Number of Incident Episodes of Complicated Malaria Per Time at Risk.
Hide Description [Not Specified]
Time Frame Time from randomization to at least 24 months of follow up or until end of the study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:

LPV/r + 2 NRTIs

LPV/r + 2 NRTIs: Group 1

Lopinavir/ritonavir (LPV/r) +2 nucleoside reverse transcriptase inhibitor (NRTI)

The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin < 8 gm/dL, in which case it will be Abacavir. Stavudine will be used in the event that a participant is unable to take Abacavir for safety or other reasons.

NVP or EFV + 2 NRTIs

NVP or EFV + 2 NRTIs: Group 2

Nevirapine (NVP) or Efavirenz (EFV) + 2 NRTI

NVP will be used for children < 3 years of age and EFV for children ≥3 years of age. The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin < 8 gm/dL, in which case it will be stavudine.

Overall Number of Participants Analyzed 84 86
Measure Type: Number
Unit of Measure: Episodes/ Person-Yr at Risk
0.024 0.026
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1, Group 2
Comments We assumed that the incidence of malaria in Group 2 would be 0.70 episodes per person-year and estimated that we would need a sample of 300 participants for the study to have 80% power to show a 35% reduction in the incidence of malaria in Group 1, at a 2-sided significance level of 0.05. We then observed an incidence of malaria in Group 2 that was higher than anticipated (2.19 episodes/person-yr) and revised the sample size to 150 participants, who would be followed for at least 6 months.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments [Not Specified]
Method Negative Binomial Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence Rate Ratio
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.06 to 11.16
Estimation Comments Group 1 represents the numerator for the rate ratio. Group 2 represents the denominator for the rate ratio.
4.Secondary Outcome
Title Estimates of the 6-month Risk of a First Episode of Malaria
Hide Description To assess the effect of ART independently of potential interactions with antimalarial therapy after treatment for malaria, we compared the two groups with respect to the time to the first episode of malaria. Cumulative risk was estimated using the Kaplan-Meier product-limit formula.
Time Frame Enrollment to 6 months follow up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Among patients who were followed for 6 months, malaria did not develop in 34 patients in the NNRTI group and 44 in the lopinavir–ritonavir group; data on 10 patients in the NNRTI group and 7 in the lopinavir–ritonavir group were censored before the 6-month follow-up assessment.
Arm/Group Title LPV/r + 2 NRTIs NVP or EFV + 2 NRTIs
Hide Arm/Group Description:

LPV/r + 2 NRTIs: Group 1

Lopinavir/ritonavir (LPV/r) +2 nucleoside reverse transcriptase inhibitor (NRTI)

The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin < 8 gm/dL, in which case it will be Abacavir. Stavudine will be used in the event that a participant is unable to take Abacavir for safety or other reasons.

NVP or EFV + 2 NRTIs: Group 2

Nevirapine (NVP) or Efavirenz (EFV) + 2 NRTI

NVP will be used for children < 3 years of age and EFV for children ≥3 years of age. The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin < 8 gm/dL, in which case it will be stavudine.

Overall Number of Participants Analyzed 84 86
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Cumulative Risk Percentage
40.7
(30.9 to 52.2)
52.5
(42.0 to 63.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LPV/r + 2 NRTIs, NVP or EFV + 2 NRTIs
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method Cox Proportional-Hazards
Comments Adjustment for repeated measures in the same patient
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.71
Confidence Interval (2-Sided) 95%
0.45 to 1.12
Estimation Comments Group 1 represents the numerator for the hazard ratio. Group 2 represents the denominator for the hazard ratio.
5.Secondary Outcome
Title 28-day Risk of Recurrent Parasitemia
Hide Description To assess the effect of potential interactions between ART and artemether–lumefantrine, the risks of recurrent parasitemia at 28 days were compared between the two groups.
Time Frame 28 days after antimalarial therapy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The risk of recurrence was assessed among patients who had had uncomplicated malaria that had been treated with artemether–lumefantrine.
Arm/Group Title LPV/r + 2 NRTIs NVP or EFV + 2 NRTIs
Hide Arm/Group Description:

LPV/r + 2 NRTIs: Group 1

Lopinavir/ritonavir (LPV/r) +2 nucleoside reverse transcriptase inhibitor (NRTI)

The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin < 8 gm/dL, in which case it will be Abacavir. Stavudine will be used in the event that a participant is unable to take Abacavir for safety or other reasons.

NVP or EFV + 2 NRTIs: Group 2

Nevirapine (NVP) or Efavirenz (EFV) + 2 NRTI

NVP will be used for children < 3 years of age and EFV for children ≥3 years of age. The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin < 8 gm/dL, in which case it will be stavudine.

Overall Number of Participants Analyzed 84 86
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Cummulative Risk Percentage
14.0
(8.7 to 22.2)
40.8
(33.9 to 48.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LPV/r + 2 NRTIs, NVP or EFV + 2 NRTIs
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Cox Proportional-Hazards
Comments Adjustment for repeated measures in same participant.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.31
Confidence Interval (2-Sided) 95%
0.14 to 0.68
Estimation Comments Group 1 represents the numerator for the hazard ratio. Group 2 represents the denominator for the hazard ratio.
6.Secondary Outcome
Title 63-day Risk of Recurrent Malaria
Hide Description To assess the effect of potential interactions between ART and artemether–lumefantrine, the risks of recurrent malaria at 63 days were compared between the two groups.
Time Frame 28 days after antimalarial therapy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The risk of recurrence was assessed among patients who had had uncomplicated malaria that had been treated with artemether–lumefantrine.
Arm/Group Title LPV/r + 2 NRTIs NVP or EFV + 2 NRTIs
Hide Arm/Group Description:

LPV/r + 2 NRTIs: Group 1

Lopinavir/ritonavir (LPV/r) +2 nucleoside reverse transcriptase inhibitor (NRTI)

The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin < 8 gm/dL, in which case it will be Abacavir. Stavudine will be used in the event that a participant is unable to take Abacavir for safety or other reasons.

NVP or EFV + 2 NRTIs: Group 2

Nevirapine (NVP) or Efavirenz (EFV) + 2 NRTI

NVP will be used for children < 3 years of age and EFV for children ≥3 years of age. The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin < 8 gm/dL, in which case it will be stavudine.

Overall Number of Participants Analyzed 84 86
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Cumulative Risk Percentage
28.1
(20.2 to 38.3)
54.2
(46.4 to 62.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LPV/r + 2 NRTIs, NVP or EFV + 2 NRTIs
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Cox Proportional-Hazards
Comments Adjustment for repeated measures in the same patient.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.41
Confidence Interval (2-Sided) 95%
0.22 to 0.76
Estimation Comments Group 1 represents the numerator in the hazard ratio. Group 2 represents the denominator in the hazard ratio.
Time Frame Time from randomization to at least 24 months of follow up or until end of the study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description

LPV/r + 2 NRTIs

LPV/r + 2 NRTIs: Group 1

Lopinavir/ritonavir (LPV/r) +2 nucleoside reverse transcriptase inhibitor (NRTI)

The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin < 8 gm/dL, in which case it will be Abacavir. Stavudine will be used in the event that a participant is unable to take Abacavir for safety or other reasons.

NVP or EFV + 2 NRTIs

NVP or EFV + 2 NRTIs: Group 2

Nevirapine (NVP) or Efavirenz (EFV) + 2 NRTI

NVP will be used for children < 3 years of age and EFV for children ≥3 years of age. The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin < 8 gm/dL, in which case it will be stavudine.

All-Cause Mortality
Group 1 Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   11/84 (13.10%)   9/86 (10.47%) 
Blood and lymphatic system disorders     
Anemia *  2/84 (2.38%)  3/86 (3.49%) 
Dehydration *  0/84 (0.00%)  1/86 (1.16%) 
Neutropenia/Absolute neutrophil count *  7/84 (8.33%)  9/86 (10.47%) 
Thrombocytopenia Platelets, decreased *  3/84 (3.57%)  1/86 (1.16%) 
Endocrine disorders     
Elevated Temperature/Fever *  2/84 (2.38%)  1/86 (1.16%) 
Gastrointestinal disorders     
Diarrhea *  1/84 (1.19%)  1/86 (1.16%) 
Vomiting *  1/84 (1.19%)  1/86 (1.16%) 
Hepatobiliary disorders     
Elevated ALT *  2/84 (2.38%)  2/86 (2.33%) 
Metabolism and nutrition disorders     
Malnutrition *  1/84 (1.19%)  0/86 (0.00%) 
Unintentional weight loss *  0/84 (0.00%)  1/86 (1.16%) 
Nervous system disorders     
Seizure *  2/84 (2.38%)  1/86 (1.16%) 
Psychiatric disorders     
Altered mental status *  0/84 (0.00%)  1/86 (1.16%) 
Renal and urinary disorders     
Hypoglycemia *  0/84 (0.00%)  1/86 (1.16%) 
Respiratory, thoracic and mediastinal disorders     
Cough *  1/84 (1.19%)  0/86 (0.00%) 
Dyspnea/respiratory distress *  4/84 (4.76%)  3/86 (3.49%) 
Skin and subcutaneous tissue disorders     
Stevens-Johnson Syndrome *  0/84 (0.00%)  1/86 (1.16%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1 Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   41/84 (48.81%)   43/86 (50.00%) 
Blood and lymphatic system disorders     
Anemia *  2/84 (2.38%)  4/86 (4.65%) 
Neutropenia *  24/84 (28.57%)  21/86 (24.42%) 
Thrombocytopenia Platelets, decreased *  9/84 (10.71%)  6/86 (6.98%) 
WBC, decreased *  1/84 (1.19%)  2/86 (2.33%) 
Endocrine disorders     
Chills *  2/84 (2.38%)  0/86 (0.00%) 
Elevated Temperature *  19/84 (22.62%)  24/86 (27.91%) 
Gastrointestinal disorders     
Diarrhea *  0/84 (0.00%)  1/86 (1.16%) 
Hepatobiliary disorders     
Elevated ALT *  2/84 (2.38%)  3/86 (3.49%) 
Elevated AST *  1/84 (1.19%)  1/86 (1.16%) 
Metabolism and nutrition disorders     
Severe Malnutrition *  0/84 (0.00%)  1/86 (1.16%) 
Unintentional weight loss *  1/84 (1.19%)  0/86 (0.00%) 
Skin and subcutaneous tissue disorders     
Pallor *  0/84 (0.00%)  1/86 (1.16%) 
Rash (non-infectious) *  0/84 (0.00%)  1/86 (1.16%) 
*
Indicates events were collected by non-systematic assessment
The study has limited statistical power for the comparison of uncommon events and limited evaluation of potential cardiotoxic effects, hence future studies of the safety of coadministration of lopinavir–ritonavir and lumefantrine are warranted.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Tamara Clark
Organization: University of California, San Francisco
Phone: 415-206-8790
Publications of Results:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00978068     History of Changes
Other Study ID Numbers: H5747-34097
NIH PO1 HD059454
2009-114 ( Other Identifier: Makerere Univ Fac of Med Research and Ethics Committee )
HS-620 ( Other Identifier: Uganda National Council for Science and Tech )
551/ESR/NDA/DID-08/09 ( Other Identifier: Uganda National Drug Authority )
H5741-34097 and 10-00991 ( Other Identifier: UCSF Committee on Human Research )
First Submitted: September 14, 2009
First Posted: September 16, 2009
Results First Submitted: November 18, 2015
Results First Posted: December 28, 2018
Last Update Posted: December 28, 2018