Trial · NCT00435929
A Study of Saquinavir/Ritonavir in Liver-Impaired Patients With HIV Infection.
NCT00435929, Phase 1, Completed, Hoffmann-La Roche; results first posted 2016-01-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Saquinavir/Ritonavir in Liver-Impaired Patients With HIV Infection. Trials, record NCT00435929. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00435929
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Saquinavir/Ritonavir in Liver-Impaired Patients With HIV Infection.
- NCT number
- NCT00435929
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 16 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- HIV Infections
- Interventions
- Ritonavir, saquinavir [Invirase]
- First posted
- 2007-02-16
- Last updated
- 2018-03-29
- Results first posted
- 2016-01-08
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours After Dosing (AUC 0-12h) of Saquinavir (SQV) and Ritonavir (RTV) | Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14 | Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. The pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the area under the plasma concentration-time curve from 0 to 12 hours after dosing (AUC (0-12h) of SQV and RTV The AUC (0-12hours) was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin. |
| Primary | Maximum Observed Plasma Concentration (Cmax) of SQV and RTV | Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14 | The plasma concentration (Cmax) is defined as maximum observed analyte concentration. The pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the maximum observed plasma concentration (C max) of SQV and Ritonavir RTV The Cmax was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin. |
| Secondary | Time of Maximum Plasma Concentration (Tmax) of SQV and RTV | Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14 | The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the time of maximum plasma concentration of SQV and RTV. The Tmax was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin. |
| Secondary | Terminal Half-life (T1/2) of SQV and RTV | Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14 | Terminal half-life is the time measured for the plasma concentration to decrease by one half. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the terminal half-life (T1/2) of SQV and RTV. The T1/2 was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin. |
| Secondary | Minimum Observed Plasma Concentration (Cmin) of SQV and RTV | Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post dose on Day 14 | Cmin is the minimum blood plasma concentration that a drug achieves. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the minimum observed plasma concentration (C min) of SQV and RTV The Cmin was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin. |
| Secondary | Plasma Clearance After Oral Administration (CL/F) of SQV and RTV | Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post dose on Day 14 | The CL/F is the oral clearance; that is clearance based on oral bioavailability. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the plasma clearance after oral administration (CL/F)of SQV and RTV The CL/F was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin. |
| Secondary | Volume of Distribution (Vd) of SQV and RTV | Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post dose on Day 14 | Vd is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. The pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the Vd of SQV and RTV The Vd was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin. |
| Secondary | Cluster of Differentiation 4 (CD4 ) Count | Screening (Day -35 to -1), pre-dose on Day 8, Day 14 and at follow up (Day 28-Day 35) | The pharmacodynamic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the cluster of differentiation 4 (CD4) count in participants in each group. |
| Secondary | Number of Participants With the Indicated Grade 3 and Grade 4 Laboratory Parameters | Up to Day 35 | Laboratory parameters specified in Clinical Operating Guidelines (COG) were summarized. AIDS Clinical Trial Group (ACTG) and American Heart Association (AHA) criteria were used to grade COG laboratory test values. Laboratory parameters for which an increase to Grade 3 (G3) or Grade 4 (G4) occurred are presented in the table below. |
| Secondary | Number Participants With Abnormal Vital Signs | Up to Day 35 | Abnormal Vital signs included are high and low Pulse rate (PR), high and how Temperature (Temp), high and low Systolic Blood Pressure (SBP) and high and low Diastolic Blood Pressure (DBP). Vital signs (SBP, DBP, PR,Temp) were measured after participants were in a semi-supine position for at least 5 minutes. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours After Dosing (AUC 0-12h) of Saquinavir (SQV) and Ritonavir (RTV) | Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14 | Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14. | ng*hr/mL | MEAN |
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) of SQV and RTV | Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14 | Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14. | ng/mL | MEAN |
| SECONDARY | Time of Maximum Plasma Concentration (Tmax) of SQV and RTV | Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14 | Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14. | hour | MEAN |
| SECONDARY | Terminal Half-life (T1/2) of SQV and RTV | Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14 | Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14. | hour | MEAN |
| SECONDARY | Minimum Observed Plasma Concentration (Cmin) of SQV and RTV | Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post dose on Day 14 | Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14. | ng/mL | MEAN |
| SECONDARY | Plasma Clearance After Oral Administration (CL/F) of SQV and RTV | Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post dose on Day 14 | Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14. | L/hr | MEAN |
| SECONDARY | Volume of Distribution (Vd) of SQV and RTV | Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post dose on Day 14 | Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14. | Litres | MEAN |
| SECONDARY | Cluster of Differentiation 4 (CD4 ) Count | Screening (Day -35 to -1), pre-dose on Day 8, Day 14 and at follow up (Day 28-Day 35) | PD analysis population: All participants who received at least 1 dose of the study medication and had at least 1 pharmacodynamic (PD) measure were included in the PD analysis population. | cells/cubic millimeter | MEAN |
| SECONDARY | Number of Participants With the Indicated Grade 3 and Grade 4 Laboratory Parameters | Up to Day 35 | Safety population: All participants who received at least 1 dose of study medication (whether or not they were withdrawn prematurely) and had safety follow-up data were included in safety analysis. | participants | NUMBER |
| SECONDARY | Number Participants With Abnormal Vital Signs | Up to Day 35 | Safety population: All participants who received at least 1 dose of study medication (whether or not they were withdrawn prematurely) and had safety follow-up data were included in safety analysis. | participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group168
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours After Dosing (AUC 0-12h) of Saquinavir (SQV) and Ritonavir (RTV) | Normal Liver Function | AUC for SQV | 28518 | Standard Deviation 20157 | ng*hr/mL |
| Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours After Dosing (AUC 0-12h) of Saquinavir (SQV) and Ritonavir (RTV) | Moderate Hepatic Impairment | AUC for SQV | 24332 | Standard Deviation 24700 | ng*hr/mL |
| Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours After Dosing (AUC 0-12h) of Saquinavir (SQV) and Ritonavir (RTV) | Normal Liver Function | AUC for RTV | 10985 | Standard Deviation 1723 | ng*hr/mL |
| Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours After Dosing (AUC 0-12h) of Saquinavir (SQV) and Ritonavir (RTV) | Moderate Hepatic Impairment | AUC for RTV | 9930 | Standard Deviation 5243 | ng*hr/mL |
| Maximum Observed Plasma Concentration (Cmax) of SQV and RTV | Normal Liver Function | Cmax of SQV | 4300 | Standard Deviation 2940 | ng/mL |
| Maximum Observed Plasma Concentration (Cmax) of SQV and RTV | Moderate Hepatic Impairment | Cmax of SQV | 3610 | Standard Deviation 3000 | ng/mL |
| Maximum Observed Plasma Concentration (Cmax) of SQV and RTV | Normal Liver Function | Cmax of RTV | 1500 | Standard Deviation 294 | ng/mL |
| Maximum Observed Plasma Concentration (Cmax) of SQV and RTV | Moderate Hepatic Impairment | Cmax of RTV | 1460 | Standard Deviation 690 | ng/mL |
| Time of Maximum Plasma Concentration (Tmax) of SQV and RTV | Normal Liver Function | Tmax of SQV | 5.00 | Standard Deviation 1.83 | hour |
| Time of Maximum Plasma Concentration (Tmax) of SQV and RTV | Moderate Hepatic Impairment | Tmax of SQV | 5.00 | Standard Deviation 2.38 | hour |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Normal Liver Function | 7 | |
| Overall Study | STARTED | Moderate Hepatic Impairment | 9 | |
| Overall Study | COMPLETED | Normal Liver Function | 7 | |
| Overall Study | COMPLETED | Moderate Hepatic Impairment | 9 | |
| Overall Study | NOT COMPLETED | Normal Liver Function | 0 | |
| Overall Study | NOT COMPLETED | Moderate Hepatic Impairment | 0 |
Source ClinicalTrials.gov
Adverse events36
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 | Diarrhoea | Gastrointestinal disorders | Normal Liver Function | 3 | 7 | |
| other | Diarrhoea | Gastrointestinal disorders | Moderate Hepatic Impairment | 1 | 9 | |
| other | Nausea | Gastrointestinal disorders | Normal Liver Function | 1 | 7 | |
| other | Nausea | Gastrointestinal disorders | Moderate Hepatic Impairment | 3 | 9 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Normal Liver Function | 0 | 7 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Moderate Hepatic Impairment | 2 | 9 | |
| other | Abdominal distension | Gastrointestinal disorders | Normal Liver Function | 0 | 7 | |
| other | Abdominal distension | Gastrointestinal disorders | Moderate Hepatic Impairment | 1 | 9 | |
| other | Dyspepsia | Gastrointestinal disorders | Normal Liver Function | 0 | 7 | |
| other | Dyspepsia | Gastrointestinal disorders | Moderate Hepatic Impairment | 1 | 9 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Normal Liver Function | ||
| Total, all-cause mortality | Moderate Hepatic Impairment | ||
| Total, other adverse events | Normal Liver Function | 3 | 7 |
| Total, other adverse events | Moderate Hepatic Impairment | 5 | 9 |
| Total, serious adverse events | Normal Liver Function | 0 | 7 |
| Total, serious adverse events | Moderate Hepatic Impairment | 1 | 9 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Normal Liver Function vs Moderate Hepatic Impairment: 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/NCT00435929
GET https://conductscience.org/api/trials/v1/NCT00435929/results?page=2