Trial · NCT02120352
Registered outcomes65
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 65
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Level Below 50 Copies/Milliliter (c/mL) at Week 32 | Week 32 | Percentage of participants with HIV-1 RNA\<50 c/mL was obtained using Food and Drug Administration (FDA) Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest as non-responders. The Intent-to-Treat Maintenance Exposed (ITT-ME) Population consisted of all randomized participants who received at least one injection or one dose of investigational product during the Maintenance Period of the study (on or after Day 1 visit). |
| Primary | Number of Participants With Protocol Defined Virologic Failure (PDVF) Until Week 32 | Up to Week 32 | Virologic failure was defined as any of the following: (1) Non-response as indicated by a less than 1.0 logarithm to base 10 (log10) c/mL decrease in plasma HIV-1 RNA after 4 weeks of starting the Induction Period, which is subsequently confirmed, unless the plasma HIV-1 RNA is \< 400 c/mL; (2) Rebound as indicated by two consecutive plasma HIV-1 RNA levels \>=200 c/mL after prior suppression to \< 200 c/mL; (3) Rebound as indicated by two consecutive plasma HIV-1 RNA that are \> 0.5 log10 c/mL increase in plasma HIV-1 RNA from the nadir value on study, where the lowest HIV-1 RNA value is \>=200 c/mL. |
| Primary | Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Induction Period) | Up to 20 weeks | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A 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 disability/incapacity, or is a congenital anomaly/birth defect, important medical events which may require medical or surgical intervention, drug-induced liver injury with hyperbilirubinaemia. |
| Primary | Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Maintenance Period) | Up to an average of 59 weeks | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A 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 disability/incapacity, or is a congenital anomaly/birth defect, important medical events which may require medical or surgical intervention, drug-induced liver injury with hyperbilirubinaemia. Data presented includes all post-baseline induction period and maintenance period adverse events, as well as long-term follow-up period adverse events for those participants who did not enter the extension period. |
| Primary | Number of Participants With Post-Baseline Adverse Events by Maximum Toxicity Grade | Up to an average of 59 weeks | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Toxicity was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Data presented includes all post-baseline treatment emergent Induction Period and MP toxicities, as well as LTFP toxicities for those participants who did not enter the extension period. Number of participants with post-Baseline adverse events by maximum toxicity Grade have been presented. |
| Primary | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters | Up to an average of 59 weeks | Clinical chemistry parameters aspartate amino transferase (AST), alanine amino transferase (ALT), alkaline phosphatase (ALP), carbon dioxide(CO2) content/bicarbonate (HCO3), cholesterol, creatine kinase (CK), glucose, low density lipoprotein (LDL) cholesterol, lipase, potassium, and sodium, total bilirubin (TBIL) and triglycerides were evaluated. Toxicity was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Data presented includes all post-baseline treatment emergent Induction Period and MP toxicities, as well as LTFP toxicities for those participants who did not enter the extension period. Number of participants with any time post-baseline maximum emergent toxicities in any of the chemistry parameters have been presented. |
| Primary | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters | Up to an average of 59 weeks | Hematology parameters hemoglobin, platelet count, total neutrophils and white blood cell count were evaluated. Toxicity was graded according to DAIDS grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Data presented includes all post-baseline treatment emergent Induction Period and MP toxicities, as well as LTFP toxicities for those participants who did not enter the extension period. Number of participants with any time post-baseline maximum emergent toxicities in any of the hematology parameters have been presented. |
| Primary | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Up to an average of 59 weeks | Urinalysis dipstick included urine occult blood, urine glucose, urine ketones, urine nitrite, urine protein and urine leukocyte. The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters can be read as positive, trace, 1+, 2+ and 3+ indicating proportional concentrations in the urine sample. Data presented includes all post-baseline dipstick results during Induction and Maintenance Periods, as well as LTFP for those participants who did not enter the extension period. |
| Secondary | Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Week -20, Week -16, Week -12, Week -8, Week -4, Day 1 | Percentage of participants with HIV-1 RNA \<200 c/mL and \<50 c/mL for oral dose of CAB 30 mg plus ABC/3TC during Induction Period was obtained using FDA Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant ART prior to the visit of interest, as non-responders. The Intent-to-Treat Exposed (ITT-E) Population consisted of all randomized participants who received at least one dose of investigational product. |
| Secondary | Absolute Values of Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Week -20, Week -16, Week -12, Week -8, Week -4, Day 1 | Plasma samples for quantitative HIV-1 RNA were collected at indicated time points. Log10 values for HIV-1 RNA have been presented. |
| Secondary | Change From Baseline in Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1 | Plasma samples for quantitative HIV-1 RNA were collected at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as: HIV-1 RNA(log 10) at post-baseline visit minus HIV-1 RNA(log 10) at Baseline. |
| Secondary | Absolute Values of Cluster of Differentiation 4+ (CD4+), for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Week -20, Week -16, Week -12, Week -4, Day 1 | Blood samples were collected at specified time points to assess CD4+ using flow cytometry. Mean and standard deviation values for CD4+ are presented. |
| Secondary | Change From Baseline in CD4+, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Baseline (Week -20) and Week -16, Week -12, Week -4, Day 1 | Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline. |
| Secondary | Number of Participants With AEs by Their Severity Grades, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Up to 20 Weeks | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the DAIDS toxicity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening. The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented. |
| Secondary | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Up to Week 20 | Hematology parameters hemoglobin, platelet count, total neutrophils and white blood cell count were evaluated. Laboratory toxicities were graded according to DAIDS grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Number of participants with any time post-baseline maximum emergent toxicities in any of the hematology parameters have been presented. |
| Secondary | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Up to 20 weeks | Clinical chemistry parameters AST, ALT, ALP, CO2/HCO3, cholesterol, CK, glucose, LDL cholesterol, lipase, potassium, and sodium, total TBIL and triglycerides were evaluated. Laboratory toxicities were graded according to DAIDS grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Number of participants with any time post-baseline maximum emergent toxicities in any of the chemistry parameters have been presented. |
| Secondary | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) | Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1 | Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline. |
| Secondary | Change From Baseline in Clinical Chemistry Parameter: Albumin (Induction Period) | Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1 | Blood samples were collected for the analysis of clinical chemistry parameter: Albumin at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline. |
| Secondary | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine (Induction Period) | Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1 | Blood samples were collected for the analysis of clinical chemistry parameters including total Bilirubin and Creatinine at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline. |
| Secondary | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1 | Blood samples were collected for the analysis of clinical chemistry parameters including total CO2, chloride, cholesterol, glucose, potassium, sodium, triglyceride and urea at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline. |
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.
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