HIV InfectionsPhase 1/2MOCHANCT03497676
More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents
A Phase 1/2 study testing Oral Cabotegravir (CAB), Oral Rilpivirine (RPV) and Long-Acting Injectable Cabotegravir (CAB LA) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 19 sites in 5 countries.
Trial summary
The purpose of this study was to determine the dosage for oral cabotegravir (CAB) and long-acting cabotegravir (CAB LA) and long-acting rilpiverine (RPV LA) and evaluate the safety, acceptability, tolerability, and pharmacokinetics (PK) of oral CAB, CAB LA, and RPV LA in virologically suppressed children and… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Oral Cabotegravir (CAB), Oral Rilpivirine (RPV) and Long-Acting Injectable Cabotegravir (CAB LA)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 19 sitesin 5 countries
- Study dates
- 3 Apr 2019to 22 Apr 2025
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Selected parents or caregivers of adolescents may be enrolled to complete qualitative phone interviews. See the study protocol for more information regarding the selection process, and coordination of scheduling the interviews. All of the following criteria must be met for the parent/caregiver to be enrolled:
- Selected by the protocol team for participation in the study
- Willing and able to provide informed (verbal or written) consent for study participation
- Per the adolescent participant, has knowledge of how the adolescent participant tolerated the study product, and lives with or has regular supportive contact with the adolescent participant
- Per parent/caregiver self-report, has knowledge of how the participant tolerated the study product, and lives with or has regular supportive contact with the adolescent participant
- Willing and able to complete interview in English by phone
- Parents and/or caregivers of participants who meet the following criterion will be excluded from study participation:
- Any condition or social circumstance that, in the opinion of the IoR or designee, would make study participation unsafe for either the parent/caregiver or the adolescent participant, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Who cannot join
None listed.
Trial locations and contacts
19 sites in 5 countries.
19 sites in 5 countries
United States8 sites
Emory University School of Medicine NICHD CRS
Atlanta, Georgia, 30322
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, 80045
Johns Hopkins Univ. Baltimore NICHD CRS
Baltimore, Maryland, 21287
Lurie Children's Hospital of Chicago (LCH) CRS
Chicago, Illinois, 60614-3393
Baylor College of Medicine/ Texas Children's Hospital NICHD CRS
Houston, Texas, 77030
Usc La Nichd Crs
Los Angeles, California, 90089
St. Jude Children's Research Hospital CRS
Memphis, Tennessee, 38105-3678
Pediatric Perinatal HIV NICHD CRS, Site 5127
Miami, Florida, 33136
South Africa4 sites
Wits RHI Shandukani Research Centre CRS
Johannesburg, 2001
Soweto CRS, Site 8052
Soweto, 1862
Famcru Crs
Tygerberg Hills, Western Cape, 7505
Umlazi CRS
Umlazi, 4066
Thailand3 sites
Siriraj Hospital Mahidol University
Bangkok, 10700
Chiangrai Prachanukroh Hospital NICHD CRS
Chiang Mai, 50100
Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS
Chiang Mai, 50200
Botswana2 sites
Gaborone CRS
Gaborone, South-East District
Molepolole CRS, Site 12702
Molepolole
About this study
Official title: Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents
The purpose of this study was to determine the dosage for oral cabotegravir (CAB) and long-acting cabotegravir (CAB LA) and long-acting rilpiverine (RPV LA) and evaluate the safety, acceptability, tolerability, and pharmacokinetics (PK) of oral CAB, CAB LA, and RPV LA in virologically suppressed children and adolescents living with HIV.
Read the detailed description
IMPAACT 2017 was a Phase I/II, multi-center, open-label, non-comparative dose-finding study with the primary objective of evaluating the safety, acceptability, tolerability, and PK of oral cabotegravir (CAB) and long-acting cabotegravir (CAB LA) as well as long-acting rilpivirine (RPV LA) in adolescents living with HIV-1, who are 12 to <18 years of age, ≥35kg, and virologically suppressed.
The study design included two cohorts of participants and five study steps. In Cohort 1, Step 1 participants received either oral CAB or oral rilpivirine (RPV) for at least four weeks and up to six weeks (maximum). In Cohort 1, Step 2 participants received intramuscular injectable formulations of the study products, either CAB LA or RPV LA. Cohort 1 participants were assigned either CAB (Cohort 1C) or RPV (Cohort 1R) based on their pre-study combination Antiretroviral Therapy (cART) regimen. Participants on a PI-based and/or NNRTI-based cART regimen were assigned to Cohort 1C, and participants on a non-boosted INSTI-based cART regimen were assigned to Cohort 1R. All participants continued their pre-study cART regimen during Cohort 1.
During Cohort 2, all participants discontinued their pre-study cART regimen and received both study products, CAB and RPV, at the doses established in Cohort 1. Cohort 2 participants enrolled to either Cohort 2A to receive both oral CAB + oral RPV (Step 3) followed by both CAB LA + RPV LA (Step 4) or Cohort 2B to directly receive both CAB LA + RPV LA without an oral lead-in phase (Step 5). If eligible, Cohort 1 participants were able to enroll into Cohort 2 (i.e., Cohort 1 Rollover). However, Cohort 2 participants who were not previously enrolled in Cohort 1 (i.e., Cohort 1-Naïve) were the primary group for analyses and conclusions. No participants enrolled into Cohort 2B, direct to injection (Step 5). Therefore, all references to Cohort 2 refer to Cohort 2A (Steps 3 and 4).
Two interim analyses were planned. The first interim analysis established the doses for Cohort 2 and determined whether to open Cohort 2 to Cohort 1 participants who met criteria to enter Cohort 2. The second interim analysis provided justification to open Cohort 2 to additional participants who were not previously enrolled in Cohort 1. A final analysis of Cohort 1 data was performed to confirm the final doses for Cohort 2.
Safety and PK evaluations were performed during Steps 1-5 and long-term safety follow-up (LSFU). Antiviral activity assessments were performed during Steps 1-5. Acceptability and tolerability were assessed during Steps 1-5 and LSFU, with all participants completing quantitative questionnaires and a subset of participants completing in-depth qualitative interviews. Additionally, parents/caregivers of a subset of U.S. participants from U.S. sites were also enrolled to complete a single in-depth qualitative interview. Because objectives related to parents/caregivers were exploratory, these outcomes are not described here.
Cohort 1 participants were followed for up to 64 weeks. Participants were followed for at least four weeks in Step 1 (oral phase) and at least 12 weeks in Step 2 (injection phase). All Step 2 participants were followed (on cART, off study product) for up to an additional 48 weeks as part of LSFU after their last study product injection. If eligible, Cohort 1 participants enrolled into Cohort 2 before completing LSFU. For Cohort 1, Step 1 participants not progressing to Step 2, the last visit was targeted to be completed 28 days after the participant's last oral study product use.
Cohort 2 participants were followed for up to 188 (Cohort 2B) or 192 (Cohort 2A) weeks. Participants were followed for at least four weeks in Step 3 (oral phase) and 92 weeks in Step 4/Step 5 (injection phase). After completing 92 weeks of follow-up in Step 4/Step 5 (injection phase), Cohort 2 participants who continued access to injectable study products through a mechanism external to the protocol exited the study. If it was not possible for participants to access injections of CAB LA + RPV LA from non-study sources at the completion of their Step 4 Week 96 or Step 5 Week 92 visit, participants remained in the study safety extension for up to 48 weeks. Participants who permanently discontinued injectable study product use during Cohort 2, Step 4/Step 5, or did not wish to continue to access the study products through the external mechanism after their Week 96 visit, were followed (on cART, off study product) for an additional 48 weeks as part of LSFU after their last study product injection, except for participants in the study safety extension. Participants in the study safety extension who decided to permanently discontinue injectable study product or who had not established access to study product after the 48 weeks in the study safety extension would exit the study (not enter LSFU). For Cohort 2, Step 3 participants not progressing to the injection phase, the last visit was targeted to be completed 28 days after the participant's last oral study product use. Female participants who discontinued study product use (either oral or injectable study product) due to pregnancy during Steps 1-5 were followed for an additional 48 weeks in LSFU to assess long-term safety and washout PK of the study products, except for participants in the study safety extension. Participants who became pregnant during the safety extension were only followed until the pregnancy outcome was determined.
- Conditions
- HIV Infections
- Being tested
- Oral Cabotegravir (CAB), Oral Rilpivirine (RPV), Long-Acting Injectable Cabotegravir (CAB LA), Long-Acting Injectable Rilpivirine (RPV LA), Combination Antiretroviral Therapy (cART)
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Cabotegravir (CAB)Drug
30 mg tablets administered orally
Oral Rilpivirine (RPV)Drug
Also called Edurant
25 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA)Drug
Administered by intramuscular (IM) injection
Long-Acting Injectable Rilpivirine (RPV LA)Drug
Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART)Drug
Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1C: CAB | Experimental | Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8). Receives: Drug: Oral Cabotegravir (CAB); Drug: Long-Acting Injectable Cabotegravir (CAB LA); Drug: Combination Antiretroviral Therapy (cART) |
| Cohort 1R: RPV | Experimental | Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8). Receives: Drug: Oral Rilpivirine (RPV); Drug: Long-Acting Injectable Rilpivirine (RPV LA); Drug: Combination Antiretroviral Therapy (cART) |
| Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA | Experimental | Step 3: CAB administered orally as one 30 mg tablet once daily and RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit for 4-6 weeks.
Step 4: First and second injections: CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection at Week 4b and at Week 8. Subsequent injections: starting at Week 16, CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection every eight weeks through Week 96 or final safety extension visit. Receives: Drug: Oral Cabotegravir (CAB); Drug: Oral Rilpivirine (RPV); Drug: Long-Acting Injectable Cabotegravir (CAB LA); Drug: Long-Acting Injectable Rilpivirine (RPV LA) |
| Cohort 2B: CAB LA + RPV LA | Experimental | Step 5: First and second injections: CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection at Entry and at Week 4. Subsequent injections: starting at Week 12, CAB LA administered as a 600 mg IM injection and RPV LA administered as 900 mg IM injection every eight weeks through Week 92 or final safety extension visit. Receives: Drug: Long-Acting Injectable Cabotegravir (CAB LA); Drug: Long-Acting Injectable Rilpivirine (RPV LA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Who Had Grade 3 or Higher Adverse Event (Cohort 1)
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Measured: Cohort 1 Treatment Initiation through Week 4
Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 1)
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE assessed as related by the site investigator of record to study product through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Measured: Cohort 1 Treatment Initiation through Week 4
Proportion of Participants Who Had Serious Adverse Events Meeting International Conference on Harmonisation (ICH) Criteria Assessed as Related to Study Product/s (Cohort 1)
Adverse events (AE) were assessed as a Serious AE by ICH criteria. Per ICH, a serious AE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see references for additional details). We present the proportion of participants with at least one serious AE assessed as related to study product by the site investigator of record through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Measured: Cohort 1 Treatment Initiation through Week 4
Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1)
We present the proportion of participants who permanently discontinued study product due to adverse events (AEs) assessed as related to study product by the site investigator of record through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Measured: Cohort 1 Treatment Initiation through Week 4
Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1)
We present the proportion of participants who died due to adverse events assessed as related to study product by the site investigator of record through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Measured: Cohort 1 Treatment Initiation through Week 4
Proportion of Participants Who Had Grade 3 or Higher Adverse Events (Cohort 1)
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Measured: Cohort 1 Treatment Initiation through Week 16
Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 1)
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Measured: Cohort 1 Treatment Initiation through Week 16
Proportion of Participants Who Had Serious Adverse Events Meeting International Conference on Harmonisation (ICH) Criteria Assessed as Related to Study Product/s (Cohort 1)
Adverse events (AE) were assessed as a Serious AE by ICH criteria. Per ICH, a serious AE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see references for additional details). We present the proportion of participants with at least one serious AE assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Measured: Cohort 1 Treatment Initiation through Week 16
Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1)
We present the proportion of participants who permanently discontinued study product due to adverse events (AEs) assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Measured: Cohort 1 Treatment Initiation through Week 16
Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1)
We present the proportion of participants who died due to adverse events assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Measured: Cohort 1 Treatment Initiation through Week 16
Proportion of Participants Who Had Grade 3 or Higher Adverse Events (Cohort 2)
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Measured: Cohort 2 Treatment Initiation through Week 24
Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 2)
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Measured: Cohort 2 Treatment Initiation through Week 24
Proportion of Participants Who Had Serious Adverse Events Meeting ICH Criteria Assessed as Related to Study Product/s (Cohort 2)
Adverse events (AE) were assessed as a Serious AE by ICH criteria. Per ICH, a serious AE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see references for additional details). We present the proportion of participants with at least one serious AE assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Measured: Cohort 2 Treatment Initiation through Week 24
Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 2)
We present the proportion of participants who permanently discontinued study product due to adverse events (AEs) assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Measured: Cohort 2 Treatment Initiation through Week 24
Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 2)
We present the proportion of participants who died due to adverse events assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Measured: Cohort 2 Treatment Initiation through Week 24
Geometric Mean Area Under the Plasma Concentration-time Curve (AUC) for Step 1 Oral CAB (Cohort 1C)
AUC calculated using non-compartmental methods with linear up-log down trapezoidal rule (Phoenix WinNonlin v 8.3, Certara®). We present the geometric mean of the AUC with associated geometric coefficient of variation.
Measured: Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8, and (for Q4W dosing) 24 hours post-dose
Apparent Total Body Clearance (CL/F) of Step 1 Oral CAB (Cohort 1C)
We present the geometric mean of the total body clearance of CAB and associated geometric coefficient of variation, based on analysis of intensive pharmacokinetic (PK) samples.
Measured: Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8 and (for Q4W dosing) 24 hours post-dose
Geometric Mean Maximum Plasma Concentration (Cmax) of Oral CAB (Cohort 1C)
We present the geometric mean of the maximum plasma concentration of CAB and associated geometric coefficient of variation, based on analysis of intensive PK samples
Measured: Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8 and (for Q4W dosing) 24 hours post-dose
Time of Maximum Concentration (Tmax) of Oral CAB (Cohort 1C)
We present the mean time of maximum concentration of CAB and associated standard deviation, based on analysis of intensive PK samples.
Measured: Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8, and (for Q4W dosing) 24 hours post-dose
Geometric Mean Pre-dose Concentration (C0) of Oral CAB (Cohort 1C)
We present the geometric mean pre-dose CAB concentration and associated geometric coefficient of variation, based on analysis of intensive PK samples.
Measured: Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8, and (for Q4W dosing) 24 hours post-dose
Geometric Mean Concentration of LA CAB/LA RPV at Week 16 (Cohort 1 Q4W)
We present the geometric mean concentration of LA CAB/LA RPV and associated geometric coefficients of variation for participants on the Q4W dosing regimen, based on analysis of pre-dose PK sample.
Measured: Week 16
Geometric Mean Maximum Plasma Concentration (Cmax) of LA CAB/LA RPV (Cohort 1 Q4W)
We present the geometric mean of the maximum plasma concentration of LA CAB/LA RPV and associated geometric coefficient of variation for the first injection in participants on the Q4W dosing regimen, based on analysis of intensive PK samples.
Measured: Samples collected at Weeks 4b, 5, 6, and 8
Time of Maximum Concentration (Tmax) of LA CAB/LA RPV (Cohort 1 Q4W)
We present the mean time of maximum concentration of LA CAB/LA RPV at the first injection and associated standard deviation for participants on the Q4W dosing regimen, based on analysis of intensive PK samples.
Measured: Samples collected at Weeks 4b, 5, 6, 8
Geometric Mean Pre-dose Concentration (C0) of LA CAB/LA RPV (Cohort 1 Q4W)
We present the geometric mean pre-dose concentrations of each injection and associated geometric coefficient of variation for participants on the Q4W dosing regimen, based on analysis of pre-dose PK samples.
Measured: Week 4b, Week 8, Week 12
Geometric Mean Concentration of LA CAB/LA RPV at Week 16 (Cohort 1 Q8W)
We present the geometric mean concentration of LA CAB/LA RPV and associated geometric coefficients of variation for participants on the Q4W dosing regimen, based on analysis of the pre-dose PK sample.
Measured: Week 16
Geometric Mean Maximum Plasma Concentration (Cmax) of LA CAB/LA RPV (Cohort 1 Q8W)
We present the geometric mean of the maximum plasma concentration of LA CAB/LA RPV and associated geometric coefficient of variation for the first injection in participants on the Q8W dosing regimen, based on analysis of intensive PK samples.
Measured: Samples collected at Weeks 4b, 5, and 8
Time of Maximum Concentration (Tmax) of LA CAB/LA RPV (Cohort 1 Q8W)
We present the mean time of maximum concentration of LA CAB/LA RPV at the first injection and associated standard deviation for participants on the Q8W dosing regimen, based on analysis of intensive PK samples.
Measured: Samples collected at Weeks 4b, 5, and 8
Geometric Mean Pre-dose Concentration (C0) of LA CAB/LA RPV (Cohort 1 Q8W)
We present the geometric mean pre-dose concentration of the first injection and associated geometric coefficient of variation for participants on the Q4W dosing regimen, based on analysis of pre-dose PK samples.
Measured: Week 4b, Week 8
Secondary outcomes (17)
Proportion of Participants With HIV-1 RNA < 50 Copies/mL (Cohort 1)
We present the proportion of participants with results of HIV-1 RNA < 50 copies/mL at Week 16
Measured: Week 16
Proportion of Participants Who Reported "Hurts Whole Lot" or "Hurts Worst" in Regards to Being Bothered by Pain During Injection of CAB LA or RPV LA (Cohort 1)
Results collected via administration of Pain During Injection survey to participants after receiving injection. Pain during injections was assessed using the Faces Pain Scale-Revised which includes 6 visual and text options: "no hurt," "hurts little bit," "hurts little more," "hurts even more," "hurts whole lot" and "hurts worst".
Measured: Week 8
Median Dimension of Quality of Life Scores
A commonly used 23-item Pediatric Quality of Life Inventory, the PedsQLTM, was used to measure physical, emotional, and social dimensions of health as well as school functioning. Question responses were used to generate scores from 0-100 (100 being the best quality of life) based on the PedsQLTM guidelines. The number of participants drops slightly for the school functioning result as not all participants are eligible to answer these school-related questions.
Measured: Week 16
Proportion of Participants Who Had Grade 3 or Higher Adverse Events (Cohort 2)
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Measured: Cohort 2 treatment initiation through Week 48
Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 2)
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE assessed as related to study product by the site investigator of record through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Measured: Cohort 2 treatment initiation through Week 48
Proportion of Participants Who Had Serious Adverse Events Meeting ICH Criteria, as Cited in References, Assessed as Related to Study Product/s (Cohort 2)
Adverse events (AE) were assessed as a Serious AE by ICH criteria. Per ICH, a serious AE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see references for additional details). We present the proportion of participants with at least one serious AE assessed as related to study product by the site investigator of record through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Measured: Cohort 2 treatment initiation through Week 48
Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 2)
We present the proportion of participants who permanently discontinued study product due to adverse events (AEs) assessed as related to study product by the site investigator of record through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Measured: Cohort 2 treatment initiation through Week 48
Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 2)
We present the proportion of participants who died due to adverse events assessed as related to study product by the site investigator of record through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Measured: Cohort 2 treatment initiation through Week 48
Proportion of Participants With Plasma HIV-1 RNA >= 50 Copies/mL Per the FDA Snapshot (Cohort 2)
We present the proportion of participants with HIV-1 RNA >= 50 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations.
Measured: Week 24
Proportion of Participants With Plasma HIV-1 RNA >= 200 Copies/mL Per the FDA Snapshot (Cohort 2)
We present the proportion of participants with HIV-1 RNA >= 200 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations.
Measured: Week 24
Proportion of Participants With Plasma HIV-1 RNA >= 50 Copies/mL Per the FDA Snapshot (Cohort 2)
We present the proportion of participants with HIV-1 RNA >= 50 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations.
Measured: Week 48
Proportion of Participants With Plasma HIV-1 RNA >= 200 Copies/mL Per the FDA Snapshot (Cohort 2)
We present the proportion of participants with HIV-1 RNA >= 200 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations.
Measured: Week 48
Geometric Mean Pre-dose Concentration (C0) of Oral CAB and Oral RPV (Cohort 2)
We present the geometric mean of the pre-dose concentration of oral CAB and oral RPV and associated coefficient of variation, based on analysis of pre-dose PK sample.
Measured: Week 2
Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 24: Pre-dose CAB and RPV Concentrations at Week 8 (Cohort 2)
We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 24:Week 8 and associated coefficient of variation, based on analysis of pre-dose PK samples.
Measured: Week 8 and Week 24
Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 24: Pre-dose CAB and RPV Concentrations at Week 16 (Cohort 2)
We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 24:Week 16 and associated coefficient of variation, based on analysis of pre-dose PK samples.
Measured: Week 16 and Week 24
Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 48: Pre-dose CAB and RPV Concentrations at Week 8 (Cohort 2)
We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 48:Week 8 and associated coefficient of variation, based on analysis of pre-dose PK samples.
Measured: Week 8 and Week 48
Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 48: Pre-dose CAB and RPV Concentrations at Week 16 (Cohort 2)
We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 48:Week 16 and associated coefficient of variation, based on analysis of pre-dose PK samples.
Measured: Week 16 and Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start3 Apr 2019
- Primary completion18 Feb 2023
- Study completion22 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- ViiV Healthcare
- Responsible party
- Sponsor
- Investigators
- Carolyn Bolton Moore, MSc, MBBCh, Study chair, Centre for Infectious Disease Research in Zambia/University of Alabama BirminghamAditya H. Gaur, MD, Study chair, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497676
- Sponsor's protocol ID
- IMPAACT 2017
- Other IDs
- 30070
- Acronym
- MOCHA
- Status last verified
- Jan 2026
- First submitted
- 6 Apr 2018
- Last updated
- 28 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie results in the publication, after deidentification.
Publications
Gaur AH, Capparelli EV, Calabrese K, Baltrusaitis K, Marzinke MA, McCoig C, Van Solingen-Ristea RM, Mathiba SR, Adeyeye A, Moye JH, Heckman B, Lowenthal ED, Ward S, Milligan R, Samson P, Best BM, Harrington CM, Ford SL, Huang J, Crauwels H, Vandermeulen K, Agwu AL, Smith-Anderson C, Camacho-Gonzalez A, Ounchanum P, Kneebone JL, Townley E, Bolton Moore C; IMPAACT 2017 Collaborators; IMPAACT 2017 Team. Safety and pharmacokinetics of oral and long-acting injectable cabotegravir or long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study. Lancet HIV. 2024 Apr;11(4):e211-e221. doi: 10.1016/S2352-3018(23)00300-4.
PubMed 38538160Lowenthal ED, Chapman J, Ohrenschall R, Calabrese K, Baltrusaitis K, Heckman B, Yin DE, Agwu AL, Harrington C, Van Solingen-Ristea RM, McCoig CC, Adeyeye A, Kneebone J, Chounta V, Smith-Anderson C, Camacho-Gonzalez A, D'Angelo J, Bearden A, Crauwels H, Huang J, Buisson S, Milligan R, Ward S, Bolton-Moore C, Gaur AH; IMPAACT 2017 Collaborators; IMPAACT 2017 Team. Acceptability and tolerability of long-acting injectable cabotegravir or rilpivirine in the first cohort of virologically suppressed adolescents living with HIV (IMPAACT 2017/MOCHA): a secondary analysis of a phase 1/2, multicentre, open-label, non-comparative dose-finding study. Lancet HIV. 2024 Apr;11(4):e222-e232. doi: 10.1016/S2352-3018(23)00301-6.
PubMed 38538161Moore CB, Baltrusaitis K, Capparelli EV, Lowenthal ED, Yin DE, Moye JH, Smith C, Whitton M, Harrington CM, Crauwels H, Van Solingen-Ristea R, Marzinke MA, Heckman B, Ace A, Ward S, Whitson K, Huang J, Cheung SYA, Best BM, Townley E, Agwu A, Ounchanum P, Mathiba SR, Aurpibul L, Korutaro V, Masheto G, Patel F, Moodley E, Gaur AH; IMPAACT 2017 Collaborators for the IMPAACT 2017 Team. Safety, antiviral activity, and pharmacokinetics of long-acting cabotegravir plus long-acting rilpivirine in virologically suppressed adolescents living with HIV-1 (IMPAACT 2017/MOCHA): week 96 and end-of-study results from a multinational, phase 1/2, single-arm trial. Lancet Child Adolesc Health. 2026 Oct 6:S2352-4642(26)00221-X. doi: 10.1016/S2352-4642(26)00221-X. Online ahead of print.
PubMed 42838065Gaur AH, Baltrusaitis K, Capparelli EV, Moye JH, Yin DE, Masheto G, Buisson S, Harrington CM, Marzinke MA, Lowenthal ED, Scheckter R, Ace A, Ward S, Milligan R, Whitson K, Huang J, Cheung SYA, Best BM, Townley E, Roberts G, Kakuda TN, Birmingham E, Mathiba SR, Aurpibul L, Korutaro V, Smith C, Patel F, Moodley E, Bolton-Moore C; IMPAACT 2017 Collaborators; IMPAACT 2017 Team. Safety, antiviral activity, and pharmacokinetics of long-acting injectable cabotegravir-rilpivirine in virologically suppressed adolescents living with HIV-1 (IMPAACT 2017/MOCHA): 48-week results of a multinational, phase 1/2, single-arm study. Lancet HIV. 2026 Feb;13(2):e85-e94. doi: 10.1016/S2352-3018(25)00242-5. Epub 2026 Jan 14.
PubMed 41547359Lowenthal ED, Chapman J, Baltrusaitis K, Kovic G, Merchant S, Branch K, Tsosie C, Vaca MZ, Heckman B, Van Solingen-Ristea RM, Harrington CM, Yin DE, Townley E, Whitton M, Agwu AL, Smith C, Paul ME, Violari A, Moodley E, Owor M, Chokephaibulkit K, Fry S, Jao J, Mitchell CD, Buisson S, Ace A, Kolobova I, Bolton-Moore C, Gaur AH; IMPAACT 2017 Collaborators; IMPAACT 2017 Team. Acceptability and tolerability of long-acting injectable cabotegravir-rilpivirine in adolescents with HIV-1 (IMPAACT 2017/MOCHA): 48-week results of a multicentre, open-label, non-comparative phase 1/2 trial. Lancet HIV. 2026 Feb;13(2):e95-e103. doi: 10.1016/S2352-3018(25)00241-3. Epub 2026 Jan 14.
PubMed 41547358Okesanya OJ, Ayeni RA, Amadin P, Ngwoke I, Amisu BO, Ukoaka BM, Ahmed MM, Oso TA, Musa SS, Lucero-Prisno DE. Advances in HIV Treatment and Vaccine Development: Emerging Therapies and Breakthrough Strategies for Long-Term Control. AIDS Res Treat. 2025 Jul 4;2025:6829446. doi: 10.1155/arat/6829446. eCollection 2025.
PubMed 40655875Moore CB, Baltrusaitis K, Best BM, Moye JH, Townley E, Violari A, Heckman B, Buisson S, Van Solingen-Ristea RM, Capparelli EV, Marzinke MA, Lowenthal ED, Ward S, Krotje C, Milligan R, Agwu AL, Huang J, Cheung SYA, McCoig C, Yin DE, Roberts G, Crauwels H, Van Eygen V, Zabih S, Masheto G, Ounchanum P, Aurpibul L, Korutaro V, Gaur AH; IMPAACT 2017 Collaborators for the IMPAACT 2017 Team. Safety of combined long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study. Lancet HIV. 2025 Mar;12(3):e191-e200. doi: 10.1016/S2352-3018(24)00344-8.
PubMed 40049924