Trial · NCT00623597
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| 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. |
| Primary | Change In Hematuria, Glycosuria And Proteinuria From Baseline | Baseline (Day 1), Week 24 and Week 48 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Plasma Trough Concentrations (Ctrough) for Ritonavir | Pre-dose at Weeks 8, 12, 24 | Plasma trough concentration is the average steady state concentration prior to morning and evening dose. Ctrough of Ritonavir was normalized to a dose of 100 mg/kg. |
| 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 Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Cmax was normalized to a dose of 50 mg/kg for Saquinavir and100 mg/kg for Ritonavir. |
| 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 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 ritonasvir was normalized to a dose of 100 mg/kg. |
| 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. | Change from baseline in plasma HIV-1 RNA was derived as Change from baseline = Log10 (HIV-1 RNA at week x) - Log10 (HIV-1 RNA at baseline) |
| 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 number of participants with HIV-1 RNA results \<400 copies/mL were reported |
| 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 number of participants with HIV-1 RNA results \<50 copies/mL were reported. |
| Secondary | Number of Participants With >1 Log Decrease From Baseline in Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA ) | From Week 8 till Week 48 | The number of participants experiencing a greater than 1 log drop from baseline (day 1) (log 10 transformed) were reported |
| Secondary | Number of Participants With Virological Failure | From Week 12 till Week 48 | Virological failure was defined as: viral load \>= 400 copies/mL on two consecutive occasions (missing visits was assumed to be above 400 copies/mL). The number of participants classified as virological failure by Age Group and viral load (≤ 10,000 copies, \>10,000 copies) were presented. |
| Secondary | Change From Baseline in Cluster Differentiation Antigen 4 (CD4) Lymphocyte Count | Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 or upon premature discontinuation | Change from Baseline in CD4+ lymphocyte count at 24 weeks and 48 weeks were presented by age group. Change from baseline in CD4+ lymphocyte count was derived as follows: Change from baseline = (CD4+ count at week 24/48) - (CD4+ count at baseline). A baseline collection was made if there was not already a value available taken within the previous 4 weeks. Baseline was on Day 1. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00623597/registered