| Primary | Number of Participants With Any Grade 2 or Higher Event in the Injection Phase | Clinical adverse event (AE) were graded using the Division of Acquired Immunodeficiency Syndrome (DAIDS) table for grading the severity of adult and pediatric AE Version 1.0, December 2004; Clarification August 2009. The grades were: 1 (mild)=Symptoms causing no or minimal interference with usual social and functional activities; 2 (moderate)= Symptoms causing greater than minimal interference with usual social and functional activities; 3 (severe)= Symptoms causing inability to perform usual social and functional activities; 4 (potentially life threatening): Symptoms causing inability to perform basic self-care functions or medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. Data has been presented for any Grade 2 or higher event in the injection phase for injection phase (Week 5- Week 41). | Safety Injection population was defined as all participants enrolled in the study who received at least one injection of study medication. | Posted | | Count of Participants | | Participants | | Up to Week 41 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injection of placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injection consisted of 800 mg of placebo. | | OG001 | Cabotegravir | Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir. |
| | | Title | Denominators | Categories |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Any Grade 2 or higher event, any Grade 2 or higher event Vs Cabotegravir | Fisher Exact | | <0.01 | | | | | | | | | | | | | | Superiority or Other | | |
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| Primary | Number of Participants Who Recieved Injection Site Reaction (ISR) Related Concomitant Medication in the Injection Phase | The concurrent medications that were consumed by participants during the injection phase were of the class nervous system, musculo-skeletal system, genito urinary systems and sex hormones, various, respiratory system, dermatologicals, alimentary tract and metabolism, sensory organs, systemic hormonal preparations, excluding sex hormones, blood and blood forming organs, cardiovascular system. The participants who took medication from any of the above class of during the injection phase (Week 5-Week 41) have been presented. | The randomized population was defined as all participants who met the study criteria and were randomly assigned to treatment in the study. | Posted | | Count of Participants | | Participants | | Up to Week 41 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injection of placebo at 3 time points at 12W intervals (W5, W17, and W29). The IM injection consisted of 800 mg of placebo. | | OG001 | Cabotegravir | Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir. |
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| Primary | Number of Participants Who Experienced Grade 2 or Higher Laboratory Results in the Injection Phase | The severity of laboratory results was graded according to the DAIDS table for grading the severity of adult and pediatric AE Version 1.0, December 2004; Clarification August 2009. The DAIDS displays events as Grades 1-5 based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening. Data for Number of participants who experienced grade 2 or higher laboratory results in the injection phase (Week 5-Week 14) have been presented. | Safety Injection population. | Posted | | Count of Participants | | Participants | | Up to Week 41 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injection of placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injection consisted of 800 mg of placebo. | | OG001 | Cabotegravir | Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir. |
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| Primary | Number of Participants Who Had Abnormal Electrocardiogram (ECG) Findings in the Injection Phase | Full 12-lead ECGs included heart rate, PR, QRS, QT and QTc intervals. Measurements were taken from the participant following 5 minutes of rest in a semi-supine position. ECGs were performed at Week 5, Week 17, Week 29 and Week 41 in the injection phase (Week 5-Week 41). ECG abnormalities characterized as abnormal-not clinically significant (A-NCS) and abnormal-clinically significant (A-CS) upto Week 41 have been presented. There were no A-CS findings for ECG in the injection phase. | Safety Population. Only those participants available at the specified time points were analyzed. | Posted | | Count of Participants | | Participants | | Up to Week 41 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injection of placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injection consisted of 800 mg of placebo. | | OG001 | Cabotegravir | Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir. |
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| Primary | Change From Baseline in Vital Sign Assessment for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in the Injection Phase | Vital signs measurements were performed for SBP and DBP following 5 minutes of rest. Baseline was defined as the first injection at Week 5 for the injection phase. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value at Week 17, Week 29 and Week 41. | Safety population. Only those participants available at the specified time points were analyzed. | Posted | | Mean | Standard Deviation | millimeters of mercury | | Baseline (Week 5) to Week 41 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injection of placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injection consisted of 800 mg of placebo. | | OG001 | Cabotegravir | Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir. |
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| Primary | Change From Baseline in Vital Sign Assessment for Heart Rate (HR) in the Injection Phase | Vital signs measurements were performed for HR following 5 minutes of rest. Baseline was defined as the first injection at Week 5 for the injection phase. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value at Week 17, Week 29 and Week 41. | Safety population. Only those participants available at the specified time points were analyzed. | Posted | | Mean | Standard Deviation | beats per minute | | Baseline (Week 5) to Week 41 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injection of placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injection consisted of 800 mg of placebo. | | OG001 | Cabotegravir | Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir. |
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| Primary | Number of Participant With ISR for the Injection Phase Defined by Maximum Grades | Common ISR included pain, erythema, nodules and any other ISR with greater or equal to 5 participants. The number of participants who experienced pain events by needle length, swelling events by needle length, bump events by needle length for injection phase by maximum grades have been presented for the injection phase (Week 5-Week 41). | Safety Injection population. | Posted | | Count of Participants | | Participants | | Up to Week 41 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injection of placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injection consisted of 800 mg of placebo. | | OG001 | Cabotegravir | Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir. |
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| Secondary | Plasma Pharmacokinetic Assessment for Area Under the Plasma Concentration-time Curve Over the Dosing Interval [AUC(0-tau)] in the Injection Phase | Blood samples for pharmacokinetic analysis were collected starting on the first day of the First Injection Phase prior to the injection. At each injection visit a blood sample was collected prior to the injection at Week 5, Week 17 and Week 29, 1 Week post-injection at Week 6, Week 18, and Week 30, and 12 Week post-injection at Week 17, Week 29, and Week 41. The sample collected 12 Week following each injection served as the pre-dose sample for the subsequent dosing interval. Two additional samples were collected 4 and 8 Week after the first injection (Week 9 and Week 13), and 1 additional sample was collected 6 Week following the second and third injections (Week 23 and Week 35). Assessment was carried out for AUC(0-tau) a measure of the amount of drug available at target tissue (in plasma) for a fixed dosing interval (i.e.12 hours). | The pharmacokinetic parameter population comprised of all participants who underwent plasma pharmacokinetic sampling and have evaluable cabotegravir parameters estimated. Only those participants available at the specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour*microgram per milliliter | | Up to Week 41 | | | | ID | Title | Description |
|---|
| OG000 | Cabotegravir | Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir. |
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| Secondary | Plasma Pharmacokinetic Assessment for Concentration at the End of the Dosing Interval (Ctau) and Maximum Observed Concentration (Cmax) in the Injection Phase | Blood samples for pharmacokinetic analysis were collected starting on the first day of the First Injection Phase prior to the injection. At each injection visit a blood sample was collected prior to the injection at Week 5, Week 17 and Week 29, 1 Week post-injection at Week 6, Week 18, and Week 30, and 12 Week post-injection at Week 17, Week 29, and Week 41. The sample collected 12 Week following each injection served as the pre-dose sample for the subsequent dosing interval. Two additional samples were collected 4 and 8 Week after the first injection (Week 9 and Week 13), and 1 additional sample was collected 6 Week following the second and third injections (Week 23 and Week 35). Assessment was carried out for Ctau defined as the concentration at the end of the dosing interval and Cmax defined as the maximum observed plasma concentration. | Pharmacokinetic parameter population. Only those participants available at the specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter | | Up to Week 41 | | | | ID | Title | Description |
|---|
| OG000 | Cabotegravir | Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir. |
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| Secondary | Plasma Pharmacokinetic Assessment for Time to Maximum Observed Concentration (Tmax), Apparent Terminal Phase Half-life for (t½) in the Injection Phase | Blood samples for pharmacokinetic analysis were collected starting on the first day of the First Injection Phase prior to the injection. At each injection visit a blood sample was collected prior to the injection at Week 5, Week 17 and Week 29, 1 Week post-injection at Week 6, Week 18, and Week 30, and 12 Week post-injection at Week 17, Week 29, and Week 41. The sample collected 12 Week following each injection served as the pre-dose sample for the subsequent dosing interval. Two additional samples were collected 4 and 8 Week after the first injection (Week 9 and Week 13), and 1 additional sample was collected 6 Week following the second and third injections (Week 23 and Week 35). Assessment was carried out for tmax defined as the time to the maximum observed plasma concentration and t½ defined as the time taken for the concentration of drug in the blood to decrease by half of the original amount. | Pharmacokinetic parameter population. Only those participants available at the specified time points were analyzed. | Posted | | Mean | Standard Deviation | days | | Up to Week 41 | | | | ID | Title | Description |
|---|
| OG000 | Cabotegravir | Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir. |
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| Secondary | Plasma Pharmacokinetic Assessment for AUC(0-tau) by Demographic Factor Body Mass Index (BMI) and Needle Length in the Injection Phase | The median BMI was 26 kilogram per meter square. Plasma pharmacokinetic assessments were performed for AUC (0-tau) by BMI, either above or below the median BMI (50 percent upper and lower, where upper summary included all participants with BMI greater than or equal to the median BMI of the population and lower summary included all participants with BMI below the median BMI). Assessments was also performed for AUC (0-tau) by needle length (1.5 inch and 2 inch). Needle length and BMI were correlated in that the longer needle was recommended for participants with BMI greater than 30 kilogram per meter square. | Pharmacokinetic parameter population. Only those participants available at the specified time point were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour*microgram per milliter | | Up to Week 41 | | | | ID | Title | Description |
|---|
| OG000 | Cabotegravir | Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir. |
| |
| Secondary | Plasma Pharmacokinetic Assessment for Ctau and Cmax by Demographic Factor BMI and Needle Length in the Injection Phase | The median BMI was 26 kilogram per meter square. Plasma pharmacokinetic assessments were performed for Ctau and Cmax by BMI, either above or below the median BMI (50 percent upper and lower, where upper summary included all participants with BMI greater than or equal to the median BMI of the population and lower summary included all participants with BMI below the median BMI. ). Assessments was also performed for Ctau and Cmax by needle length (1.5 inch and 2 inch). Needle length and BMI were correlated in that the longer needle was recommended for participants with BMI greater than 30 kilogram per meter square. | Pharmacokinetic parameter population. Only those participants available at the specified time point were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliter | | Up to Week 41 | | | | ID | Title | Description |
|---|
| OG000 | Cabotegravir | Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir. |
| |
| Secondary | Plasma Pharmacokinetic Assessment for Tmax and t½ by Demographic Factor BMI and Needle Length in the Injection Phase | The median BMI was 26 kilogram per meter square. Plasma pharmacokinetic assessments were performed for tmax and t½ by BMI, either above or below the median BMI (50 percent upper and lower, where upper summary included all participants with BMI greater than or equal to the median BMI of the population and lower summary included all participants with BMI below the median BMI). Assessments was also performed for tmax and t½ by needle length (1.5 inch and 2 inch). Needle length and BMI were correlated in that the longer needle was recommended for participants with BMI greater than 30 kilogram per meter square. | Pharmacokinetic parameter population. Only those participants available at the specified time point were analyzed. | Posted | | Mean | Standard Deviation | Days | | Up to Week 41 | | | | ID | Title | Description |
|---|
| OG000 | Cabotegravir | Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir. |
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| Secondary | Number of Participants With Severity of ISRs and ISR Symptoms for Injection Phase Defined by Grades and Needle Length | Acceptability of cabetogravir injections was assessed number of participants who had severe ISRs and ISR symptom. ISR examination for severity included an assessment of pain, pruritis, warm to touch, bruising, discoloration, erythema, swelling, induration and bump events. Common ISR Symptoms for Injection Phase included pain, erythema, nodules and any other ISRs with greater or equal to five participants. Data has been presented for the injection phase (W5-W41) by grades and needle length. | Safety injection population. | Posted | | Count of Participants | | Participants | | Up to Week 41 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injection of placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injection consisted of 800 mg of placebo. | | OG001 | Cabotegravir | Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir. |
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| Secondary | Number of Participants With AE, Grade 2-4 AE and Serious Adverse Events (SAE) in the Oral Phase | Clinical AE were graded using the DAIDS table for grading the severity of adult and pediatric AE Version 1.0, December 2004; Clarification August 2009. The grades were: 1 (mild)=Symptoms causing no or minimal interference with usual social and functional activities; 2 (moderate)= Symptoms causing greater than minimal interference with usual social and functional activities; 3 (severe)= Symptoms causing inability to perform usual social and functional activities; 4 (potentially life threatening): Symptoms causing inability to perform basic self-care functions or medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. Data has been presented for any Grade 2 or higher event in the injection phase for injection phase (Week 5- Week 41). | | Posted | | Count of Participants | | Participants | | Up to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injection of placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injection consisted of 800 mg of placebo. | | OG001 | Cabotegravir |
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| Secondary | Number of Participants Who Received Concurrent Medication in Overall Study Duration | The concurrent medications that were consumed by participants during the injection phase were of the class nervous system, musculo-skeletal system, genito-urinary systems and sex hormones, various, respiratory system, dermatologicals, alimentary tract and metabolism, anti-infectives for systemic use, sensory organs, systemic hormonal preparations excluding sex hormones, blood and blood forming organs, cardiovascular system, anti-neoplastic and immunomodulating agents, anti-parasitic products, insecticides and repellents . The participants who took medication from any of the above class of during the during the overall study duration injection phase (Day 1 until Week 41) have been presented. | The Randomized Population comprised of all participants who met study criteria were randomly assigned to treatment in the study with the exception of any participants with documented evidence of not having consumed any amount of study medication. | Posted | | Count of Participants | | Participants | | Up to Week 41 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injection of placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injection consisted of 800 mg of placebo. | |
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| Secondary | Number of Participants Who Experienced Maximum Clinical Chemistry Including Liver Chemistry and Hematology Toxicities in the Oral Phase by Grades | The severity of clinical chemistry including liver chemistry and hematology toxicities was graded according to the DAIDS table for grading the severity of adult and pediatric AE Version 1.0, December 2004; Clarification August 2009. The DAIDS displays events as Grades 1-5 based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening. Data for maximum clinical chemistry and hematology toxicities for oral phase (Day 1 upto Week 4) by grades have been presented. | | Posted | | Count of Participants | | Participants | | Up to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injection of placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injection consisted of 800 mg of placebo. | | OG001 | Cabotegravir | Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir. |
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