Trial · NCT00623597
A Study of Invirase (Saquinavir)/Ritonavir in HIV-Infected Infants and Children.
NCT00623597, Phase 2, Completed, Hoffmann-La Roche; results first posted 2016-01-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Invirase (Saquinavir)/Ritonavir in HIV-Infected Infants and Children. Trials, record NCT00623597. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00623597
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Invirase (Saquinavir)/Ritonavir in HIV-Infected Infants and Children.
- NCT number
- NCT00623597
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- HIV Infections
- Interventions
- ritonavir, saquinavir [Invirase]
- First posted
- 2008-02-26
- Last updated
- 2016-03-07
- Results first posted
- 2016-01-14
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Plasma Trough Concentrations (Ctrough) for Saquinavir | Pre-dose at Weeks 8, 12, 24. | Plasma trough concentration is the average steady state concentration prior to morning and evening dose. Ctrough of Saquinavir was normalized to a dose of 50 mg/kg. |
| Primary | Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to Twelve Hours (AUC0-12h) for Saquinavir | Pre-dose and 3, 4, 8, 12 hours (post-dose) on Day 14 (± 2 days), or Day 28(+ 2 days) for patients switching from an Non-nucleoside reverse transcriptase inhibitor [NNRTI] containing regimen). | The area under the plasma concentration-time curve from time zero to twelve hours (AUC0-12h) is area under the plasma concentration-time curve from time zero through actual tlast. The area under the plasma concentration-time curve from time zero to twelve hours of saquinavir was normalized to a dose of 50 mg/kg. |
| Primary | Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) | From Baseline (Day 1) till Week 48 and Follow-up (Week 52) | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes |
| Primary | Change In Hematocrit From Baseline | Baseline (Day 1), Week 24 and Week 48 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Primary | Change In Hemoglobin, Total Protein And Total Albumin From Baseline | Baseline (Day 1), Week 24 and Week 48 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Primary | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Baseline (Day 1), Week 24 and Week 48 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Primary | Change In Red Blood Cell (RBC) Counts From Baseline | Baseline (Day 1), Week 24 and Week 48 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Primary | Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | Baseline (Day 1), Week 24 and Week 48 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Primary | Change In Total Bilirubin, Creatinine, Uric Acid From Baseline | Baseline (Day 1), Week 24 and Week 48 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Primary | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Baseline (Day 1), Week 24 and Week 48 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Plasma Trough Concentrations (Ctrough) for Saquinavir | Pre-dose at Weeks 8, 12, 24. | The pharmacokinetics Analysis Population (PKP) comprised all the participants from whom blood samples for pharmacokinetic analysis were collected. Participants could be excluded from the PKP if no reliable PK parameters could be determined or if justified by circumstances (e.g. vomiting after drug administration) and in agreement with the sponsor. | ng/mL | MEAN |
| PRIMARY | Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to Twelve Hours (AUC0-12h) for Saquinavir | Pre-dose and 3, 4, 8, 12 hours (post-dose) on Day 14 (± 2 days), or Day 28(+ 2 days) for patients switching from an Non-nucleoside reverse transcriptase inhibitor [NNRTI] containing regimen). | The pharmacokinetics Analysis Population (PKP) comprised all the participants from whom blood samples for pharmacokinetic analysis were collected. Participants could be excluded from the PKP if no reliable PK parameters could be determined or if justified by circumstances (e.g. vomiting after drug administration) and in agreement with the sponsor. | h*ug/mL | MEAN |
| PRIMARY | Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) | From Baseline (Day 1) till Week 48 and Follow-up (Week 52) | The Safety Analysis Population (SAP) comprised all participants who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses. | participants | NUMBER |
| PRIMARY | Change In Hematocrit From Baseline | Baseline (Day 1), Week 24 and Week 48 | The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses. | fraction | MEAN |
| SECONDARY | Plasma Trough Concentrations (Ctrough) for Ritonavir | Pre-dose at Weeks 8, 12, 24 | The PKP population comprised all the participants from whom blood samples for pharmacokinetic analysis were collected. Participants could be excluded from the PKP if no reliable PK parameters could be determined or if justified by circumstances (e.g. vomiting after drug administration) and in agreement with the sponsor. | ng/mL | MEAN |
| SECONDARY | Maximum Observed Concentration (Cmax) for Saquinavir and Ritonavir | Pre-dose and 3, 4, 8, 12 hours (post-dose) on Day 14 (± 2 days), or Day 28(+ 2 days) for patients switching from an NNRTI containing regimen and at Week 24 | The PKP population comprised all the participants from whom blood samples for pharmacokinetic analysis were collected. Participants could be excluded from the PKP if no reliable PK parameters could be determined or if justified by circumstances (e.g. vomiting after drug administration) and in agreement with the sponsor. | ng/mL | MEAN |
| SECONDARY | Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to Twelve Hours (AUC0-12h) for Ritonavir | Pre-dose and 3, 4, 8, 12 hours (post-dose) on Day 14 (± 2 days), or Day 28(+ 2 days) for patients switching from an NNRTI containing regimen). | The PKP population comprised all the participants from whom blood samples for pharmacokinetic analysis were collected. Participants could be excluded from the PKP if no reliable PK parameters could be determined or if justified by circumstances (e.g. vomiting after drug administration) and in agreement with the sponsor. | h*ug/mL | MEAN |
| SECONDARY | Change From Baseline in Mean Human Immunodeficiency Virus Viral Load | Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 (or upon premature discontinuation); a baseline collection was made if there was not already a value available taken within the previous 4 weeks. | The Safety Analysis Population (SAP) comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses. | log10 copies/mL | MEAN |
| SECONDARY | Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <400 Copies/mL | Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 (or upon premature discontinuation); a baseline collection was made if there was not already a value available taken within the previous 4 weeks. | The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses. | participants | NUMBER |
| SECONDARY | Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <50 Copies/mL | Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 (or upon premature discontinuation); a baseline collection was made if there was not already a value available taken within the previous 4 weeks. | The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses. | participants | NUMBER |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group288
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Plasma Trough Concentrations (Ctrough) for Saquinavir | Group A | 645 | Standard Deviation 536 | ng/mL | |
| Plasma Trough Concentrations (Ctrough) for Saquinavir | Group B | 1860 | Standard Deviation 1060 | ng/mL | |
| Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to Twelve Hours (AUC0-12h) for Saquinavir | Group A | 18.7 | Standard Deviation 20.0 | h*ug/mL | |
| Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to Twelve Hours (AUC0-12h) for Saquinavir | Group B | 38 | Standard Deviation 18.1 | h*ug/mL | |
| Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) | Group A | Any serious adverse events | 1 | participants | |
| Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) | Group B | Any serious adverse events | 2 | participants | |
| Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) | Total | Any serious adverse events | 3 | participants | |
| Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) | Group A | Any non-serious adverse events | 5 | participants | |
| Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) | Group B | Any non-serious adverse events | 9 | participants | |
| Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) | Total | Any non-serious adverse events | 14 | participants |
1 to 10 of 288Source ClinicalTrials.gov
See all 288 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group A | 5 | |
| Overall Study | STARTED | Group B | 13 | |
| Overall Study | COMPLETED | Group A | 4 | |
| Overall Study | COMPLETED | Group B | 13 | |
| Overall Study | NOT COMPLETED | Group A | 1 | |
| Overall Study | NOT COMPLETED | Group B | 0 |
Source ClinicalTrials.gov
Adverse events102
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 | Upper Respiratory Tract Infection | Infections and infestations | Group A | 1 | 5 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Group B | 1 | 13 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Total | 2 | 18 | |
| other | Bronchitis | Infections and infestations | Group A | 0 | 5 | |
| other | Bronchitis | Infections and infestations | Group B | 2 | 13 | |
| other | Bronchitis | Infections and infestations | Total | 2 | 18 | |
| other | Impetigo | Infections and infestations | Group A | 0 | 5 | |
| other | Impetigo | Infections and infestations | Group B | 1 | 13 | |
| other | Impetigo | Infections and infestations | Total | 1 | 18 | |
| other | Otitis Media | Infections and infestations | Group A | 0 | 5 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A | ||
| Total, all-cause mortality | Group B | ||
| Total, all-cause mortality | Total | ||
| Total, other adverse events | Group A | 5 | 5 |
| Total, other adverse events | Group B | 9 | 13 |
| Total, other adverse events | Total | 14 | 18 |
| Total, serious adverse events | Group A | 1 | 5 |
| Total, serious adverse events | Group B | 2 | 13 |
| Total, serious adverse events | Total | 3 | 18 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00623597
GET https://conductscience.org/api/trials/v1/NCT00623597/registered?page=2