Trial · NCT02120352
A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Antiretroviral Therapy-Naive Adult Subjects
NCT02120352, Phase 2, Completed, ViiV Healthcare; results first posted 2020-08-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Antiretroviral Therapy-Naive Adult Subjects. Trials, record NCT02120352. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02120352
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Antiretroviral Therapy-Naive Adult Subjects
- NCT number
- NCT02120352
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 309 participants, actual
- Lead sponsor
- ViiV Healthcare
- Conditions
- Infection, Human Immunodeficiency Virus, HIV Infections
- Interventions
- CAB Oral Tablets, CAB LA, ABC/3TC Oral tablets, RPV Oral Tablets, HAART, RPV
- First posted
- 2014-04-22
- Last updated
- 2024-06-12
- Other registries' IDs
- eudract:2013-000783-29
- Results first posted
- 2020-08-31
Source ClinicalTrials.gov
Registered outcomes65
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 65Source ClinicalTrials.gov
See all 65 registered outcomesOutcomes65
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | ITT-ME Population | Percentage of participants | NUMBER |
| PRIMARY | Number of Participants With Protocol Defined Virologic Failure (PDVF) Until Week 32 | Up to Week 32 | ITT-ME Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Induction Period) | Up to 20 weeks | Safety Population. It consists of all enrolled subjects who received at least one dose of investigational product during induction period. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | Safety Maintenance Population. It consisted of all participants who entered the Maintenance period and received at least one dose of investigational product. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Post-Baseline Adverse Events by Maximum Toxicity Grade | Up to an average of 59 weeks | Safety Maintenance Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters | Up to an average of 59 weeks | Safety Maintenance Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters | Up to an average of 59 weeks | Safety Maintenance Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Up to an average of 59 weeks | Safety Maintenance Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | Participants | COUNT_OF_PARTICIPANTS |
| 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 | ITT-E Population | Percentage of participants | NUMBER |
| 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 | ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Log10 copies per milliliter | MEAN |
1 to 10 of 65Source ClinicalTrials.gov
See all 65 outcomesResults by group904
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Level Below 50 Copies/Milliliter (c/mL) at Week 32 | CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | 95 | Percentage of participants | ||
| Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Level Below 50 Copies/Milliliter (c/mL) at Week 32 | CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | 94 | Percentage of participants | ||
| Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Level Below 50 Copies/Milliliter (c/mL) at Week 32 | CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | 91 | Percentage of participants | ||
| Number of Participants With Protocol Defined Virologic Failure (PDVF) Until Week 32 | CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | 1 | Participants | ||
| Number of Participants With Protocol Defined Virologic Failure (PDVF) Until Week 32 | CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | 0 | Participants | ||
| Number of Participants With Protocol Defined Virologic Failure (PDVF) Until Week 32 | CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | 1 | Participants | ||
| Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Induction Period) | CAB 30 mg+ABC/3TC QD (Induction Period) | Any non-SAE | 246 | Participants | |
| Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Induction Period) | CAB 30 mg+ABC/3TC QD (Induction Period) | Any SAE | 8 | Participants | |
| Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Maintenance Period) | CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Any non-SAE | 115 | Participants | |
| Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Maintenance Period) | CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Any non-SAE | 113 | Participants |
1 to 10 of 904Source ClinicalTrials.gov
See all 904 results by groupParticipant flow84
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction Period (20 Weeks) | STARTED | CAB 30 mg+ABC/3TC QD (Induction Period) | 309 | |
| Induction Period (20 Weeks) | STARTED | CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | 0 | |
| Induction Period (20 Weeks) | STARTED | CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | 0 | |
| Induction Period (20 Weeks) | STARTED | CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | 0 | |
| Induction Period (20 Weeks) | STARTED | Optimized CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Extension Period) | 0 | |
| Induction Period (20 Weeks) | STARTED | Optimized CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Extension Period) | 0 | |
| Induction Period (20 Weeks) | STARTED | Long-Term Follow-Up Group | 0 | |
| Induction Period (20 Weeks) | COMPLETED | CAB 30 mg+ABC/3TC QD (Induction Period) | 288 | |
| Induction Period (20 Weeks) | COMPLETED | CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | 0 | |
| Induction Period (20 Weeks) | COMPLETED | CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | 0 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 participant flowAdverse events1,680
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site pain | General disorders | CAB 30 mg+ABC/3TC QD (Induction Period) | 0 | 309 | 0 |
| other | Injection site pain | General disorders | CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | 111 | 115 | 2,749 |
| other | Injection site pain | General disorders | CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | 114 | 115 | 3,533 |
| other | Injection site pain | General disorders | CAB 30 mg+ABC/3TC QD | 0 | 56 | 0 |
| other | Injection site pain | General disorders | Optimized CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Extension Period) | 31 | 34 | 486 |
| other | Injection site pain | General disorders | Optimized CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Extension Period) | 8 | 10 | 197 |
| other | Injection site pain | General disorders | Long-Term Follow-Up Group | 4 | 43 | 4 |
| other | Injection site swelling | General disorders | CAB 30 mg+ABC/3TC QD (Induction Period) | 0 | 309 | 0 |
| other | Injection site swelling | General disorders | CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | 41 | 115 | 209 |
| other | Injection site swelling | General disorders | CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | 43 | 115 | 293 |
1 to 10 of 1,680Source ClinicalTrials.gov
See all 1,680 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CAB 30 mg+ABC/3TC QD (Induction Period) | 1 | 309 |
| Total, all-cause mortality | CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | 0 | 115 |
| Total, all-cause mortality | CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | 3 | 115 |
| Total, all-cause mortality | CAB 30 mg+ABC/3TC QD | 0 | 56 |
| Total, all-cause mortality | Optimized CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Extension Period) | 0 | 34 |
| Total, all-cause mortality | Optimized CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Extension Period) | 0 | 10 |
| Total, all-cause mortality | Long-Term Follow-Up Group | 0 | 43 |
| Total, other adverse events | CAB 30 mg+ABC/3TC QD (Induction Period) | 145 | 309 |
| Total, other adverse events | CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | 115 | 115 |
| Total, other adverse events | CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | 115 | 115 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT02120352
GET https://conductscience.org/api/trials/v1/NCT02120352/registered?page=2