Trial · NCT00978068
HIV Protease Inhibitors for the Prevention of Malaria in Ugandan Children
NCT00978068, Phase 3, Completed, University of California, San Francisco; results first posted 2018-12-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. HIV Protease Inhibitors for the Prevention of Malaria in Ugandan Children. Trials, record NCT00978068. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00978068
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- HIV Protease Inhibitors for the Prevention of Malaria in Ugandan Children
- NCT number
- NCT00978068
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 176 participants, actual
- Lead sponsor
- University of California, San Francisco
- Conditions
- Malaria, HIV Infections
- Interventions
- Lopinavir/Ritonavir (LPV/r), Nevirapine (NVP), Efavirenz (EFV), 2 nucleoside reverse transcriptase inhibitor (NRTI)
- First posted
- 2009-09-16
- Last updated
- 2018-12-28
- Results first posted
- 2018-12-28
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence-density of Malaria Defined as the Number of Incident Episodes of Malaria Per Time at Risk. | Time from randomization to at least 24 months of follow up or until end of the study | |
| Secondary | Percentage of Uncomplicated Malaria Episodes With Accompanying Adverse Events That Occurred in the 28 Days Following Antimalarial Therapy | 28 days after antimalarial therapy | 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). |
| Secondary | Incidence-density of Malaria Defined as the Number of Incident Episodes of Complicated Malaria Per Time at Risk. | Time from randomization to at least 24 months of follow up or until end of the study | |
| Secondary | Estimates of the 6-month Risk of a First Episode of Malaria | Enrollment to 6 months follow up | 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. |
| Secondary | 28-day Risk of Recurrent Parasitemia | 28 days after antimalarial therapy | 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. |
| Secondary | 63-day Risk of Recurrent Malaria | 28 days after antimalarial therapy | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence-density of Malaria Defined as the Number of Incident Episodes of Malaria Per Time at Risk. | Time from randomization to at least 24 months of follow up or until end of the study | Episodes/ Person-Yr at Risk | NUMBER | |
| SECONDARY | Percentage of Uncomplicated Malaria Episodes With Accompanying Adverse Events That Occurred in the 28 Days Following Antimalarial Therapy | 28 days after antimalarial therapy | % uncomplicated malaria episodes w/ AEs | NUMBER | |
| SECONDARY | Incidence-density of Malaria Defined as the Number of Incident Episodes of Complicated Malaria Per Time at Risk. | Time from randomization to at least 24 months of follow up or until end of the study | Episodes/ Person-Yr at Risk | NUMBER | |
| SECONDARY | Estimates of the 6-month Risk of a First Episode of Malaria | Enrollment to 6 months follow up | 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. | Cumulative Risk Percentage | NUMBER |
| SECONDARY | 28-day Risk of Recurrent Parasitemia | 28 days after antimalarial therapy | The risk of recurrence was assessed among patients who had had uncomplicated malaria that had been treated with artemether-lumefantrine. | Cummulative Risk Percentage | NUMBER |
| SECONDARY | 63-day Risk of Recurrent Malaria | 28 days after antimalarial therapy | The risk of recurrence was assessed among patients who had had uncomplicated malaria that had been treated with artemether-lumefantrine. | Cumulative Risk Percentage | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence-density of Malaria Defined as the Number of Incident Episodes of Malaria Per Time at Risk. | Group 1: LPV/r + 2 NRTIs | 1.32 | Episodes/ Person-Yr at Risk | ||
| Incidence-density of Malaria Defined as the Number of Incident Episodes of Malaria Per Time at Risk. | Group 2: Nevirapine (NVP) or Efavirenz (EFV) + 2 NRTIs | 2.25 | Episodes/ Person-Yr at Risk | ||
| Percentage of Uncomplicated Malaria Episodes With Accompanying Adverse Events That Occurred in the 28 Days Following Antimalarial Therapy | LPV/r + 2 NRTIs | 71.0 | % uncomplicated malaria episodes w/ AEs | ||
| Percentage of Uncomplicated Malaria Episodes With Accompanying Adverse Events That Occurred in the 28 Days Following Antimalarial Therapy | NVP or EFV + 2 NRTIs | 79.3 | % uncomplicated malaria episodes w/ AEs | ||
| Incidence-density of Malaria Defined as the Number of Incident Episodes of Complicated Malaria Per Time at Risk. | Group 1 | 0.024 | Episodes/ Person-Yr at Risk | ||
| Incidence-density of Malaria Defined as the Number of Incident Episodes of Complicated Malaria Per Time at Risk. | Group 2 | 0.026 | Episodes/ Person-Yr at Risk | ||
| Estimates of the 6-month Risk of a First Episode of Malaria | LPV/r + 2 NRTIs | 40.7 | 95% Confidence Interval 30.9 to 52.2 | Cumulative Risk Percentage | |
| Estimates of the 6-month Risk of a First Episode of Malaria | NVP or EFV + 2 NRTIs | 52.5 | 95% Confidence Interval 42.0 to 63.9 | Cumulative Risk Percentage | |
| 28-day Risk of Recurrent Parasitemia | LPV/r + 2 NRTIs | 14.0 | 95% Confidence Interval 8.7 to 22.2 | Cummulative Risk Percentage | |
| 28-day Risk of Recurrent Parasitemia | NVP or EFV + 2 NRTIs | 40.8 | 95% Confidence Interval 33.9 to 48.6 | Cummulative Risk Percentage |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LPV/r + 2 NRTIs | 87 | |
| Overall Study | STARTED | NVP or EFV + 2 NRTIs | 89 | |
| Overall Study | Initiated Study Drugs | LPV/r + 2 NRTIs | 84 | |
| Overall Study | Initiated Study Drugs | NVP or EFV + 2 NRTIs | 86 | |
| Overall Study | COMPLETED | LPV/r + 2 NRTIs | 83 | |
| Overall Study | COMPLETED | NVP or EFV + 2 NRTIs | 80 | |
| Overall Study | NOT COMPLETED | LPV/r + 2 NRTIs | 4 | |
| Overall Study | NOT COMPLETED | NVP or EFV + 2 NRTIs | 9 |
Source ClinicalTrials.gov
Adverse events58
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Group 1 | 2 | 84 | |
| other | Anemia | Blood and lymphatic system disorders | Group 2 | 4 | 86 | |
| other | Chills | Endocrine disorders | Group 1 | 2 | 84 | |
| other | Chills | Endocrine disorders | Group 2 | 0 | 86 | |
| other | Diarrhea | Gastrointestinal disorders | Group 1 | 0 | 84 | |
| other | Diarrhea | Gastrointestinal disorders | Group 2 | 1 | 86 | |
| other | Elevated ALT | Hepatobiliary disorders | Group 1 | 2 | 84 | |
| other | Elevated ALT | Hepatobiliary disorders | Group 2 | 3 | 86 | |
| other | Elevated AST | Hepatobiliary disorders | Group 1 | 1 | 84 | |
| other | Elevated AST | Hepatobiliary disorders | Group 2 | 1 | 86 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 | ||
| Total, all-cause mortality | Group 2 | ||
| Total, other adverse events | Group 1 | 41 | 84 |
| Total, other adverse events | Group 2 | 43 | 86 |
| Total, serious adverse events | Group 1 | 11 | 84 |
| Total, serious adverse events | Group 2 | 9 | 86 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Group 1 vs Group 2: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00978068
GET https://conductscience.org/api/trials/v1/NCT00978068/events?page=2