Trial · NCT02720094
Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men
NCT02720094, Phase 2, Phase 3, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2023-11-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men. Trials, record NCT02720094. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02720094
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men
- NCT number
- NCT02720094
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 4,570 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- HIV Infections
- Interventions
- Cabotegravir Oral Tablet, TDF/FTC tablets, Placebo for TDF/FTC tablets, Placebo for cabotegravir oral tablet, CAB LA, Placebo for CAB LA
- First posted
- 2016-03-25
- Last updated
- 2026-03-19
- Results first posted
- 2023-11-24
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Documented Incident HIV Infections During Steps 1 and 2 | HIV tests at enrollment, weeks 2, 4, 5, every injection visit (every 8 weeks) and every safety visit (2 weeks after each injection visit). Analyzed through week 153 or the date of DSMB decision to unblind all participants, whichever is earliest. | All HIV infections included in this analysis have been reviewed and confirmed by an independent, blinded Endpoint Adjudication Committee (EAC). |
| Primary | Number of Participants Experiencing Grade 2 or Higher Clinical and Laboratory Adverse Events | Treatment emergent AE* measured with onset date through participant's last study visit, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks). | The primary safety endpoint analyses included Grade 2 or higher clinical and laboratory AEs during Steps 1 and 2. |
| Secondary | Number of Participants With Documented Incident HIV Infections in Step 2 | HIV tests at enrollment, weeks 2, 4, 5, every injection visit (every 8 weeks) and every safety visit (2 weeks after each injection visit). Analyzed through week 153 or the date of DSMB decision to unblind all participants, whichever is earliest. | Evaluate incident HIV-1infections occurring only during Step 2, using the Injection Step 2 Efficacy population |
| Secondary | Changes From Baseline in Creatinine and Creatinine Clearance Levels | Reported week 57 (injection visit #8) and week 105 (injection visit #14) | Change from baseline at each visit is the difference between the creatine (and creatinine clearance) value as measured on the date of visit, compared to the value as measured at the enrollment visit. |
| Secondary | Number of Participants With Grade 3 or 4 Liver-related Adverse Events (AEs) | Treatment emergent AE measured with onset date through participant's last study visit, or the date of DSMB decision to unblind all participants, whichever is first. Assessed at each visit. (Injection visits q 8 weeks and safety visits q 8 weeks) | Laboratory assessment of alanine aminotransferase (ALT), aspartate aminotransferase (AST), TBili, creatine phosphokinase (CPK), or clinical assessment of jaundice/icterus. |
| Secondary | Incidence of Resistance Mutations to Study Products (Including But Not Limited to K65R, M184V/I, Q148R) Among Seroconverters | Measured from date of detection of infection, up to 4 years after study entry, with timing/intervals as determined by the HPTN laboratory center | Frequency of the detection of specific viral mutations known to confer resistance to specific classes of antiviral drugs as identified in specimens collected from infected participants during follow-up after HIV infection. |
| Secondary | Changes in Weight From Baseline | Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Collected at each injection visit (every 8 weeks). | Change in weight from baseline is the difference between the weight (kg) as collected at each study visit and the weight collected at the enrollment visit. |
| Secondary | Changes in Systolic Blood Pressure From Baseline | Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each injection visit (every 8 weeks). | Change in blood pressure from baseline is the difference between the blood pressure as collected at each study visit and the blood pressure collected at the enrollment visit. Reported in separate tables for systole and diastole. |
| Secondary | Changes in Diastolic Blood Pressure From Baseline | Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each injection visit (every 8 weeks). | Change in blood pressure from baseline is the difference between the blood pressure as collected at each study visit and the blood pressure collected at the enrollment visit. Reported in separate tables for systole and diastole. |
| Secondary | Changes in Pulse Rate From Baseline | Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each injection visit (every 8 weeks). | Change in pulse rate from baseline is the difference between the pulse rate as collected at each study visit and the pulse rate collected at the enrollment visit. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Documented Incident HIV Infections During Steps 1 and 2 | HIV tests at enrollment, weeks 2, 4, 5, every injection visit (every 8 weeks) and every safety visit (2 weeks after each injection visit). Analyzed through week 153 or the date of DSMB decision to unblind all participants, whichever is earliest. | mITT Population (Steps 1 and 2): Participants who were inappropriately enrolled are excluded. Participants who were found by the EAC to be HIV infected at enrollment are excluded. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Experiencing Grade 2 or Higher Clinical and Laboratory Adverse Events | Treatment emergent AE* measured with onset date through participant's last study visit, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks). | Inappropriately enrolled participants, participants with invalid ID due to duplicate screening or enrollment and participants who did not receive any oral study drug are excluded. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Documented Incident HIV Infections in Step 2 | HIV tests at enrollment, weeks 2, 4, 5, every injection visit (every 8 weeks) and every safety visit (2 weeks after each injection visit). Analyzed through week 153 or the date of DSMB decision to unblind all participants, whichever is earliest. | Injection step 2 efficacy: The subgroup of the mITT population who received at least one injection and had at least one HIV result assessed after the first injection visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Changes From Baseline in Creatinine and Creatinine Clearance Levels | Reported week 57 (injection visit #8) and week 105 (injection visit #14) | All subjects who received at least one dose of study product, and for whom have results for creatine and creatinine clearance at enrollment AND for at least one of the following two time points: Week 57 and Week 105. | umol/L | MEDIAN |
| SECONDARY | Number of Participants With Grade 3 or 4 Liver-related Adverse Events (AEs) | Treatment emergent AE measured with onset date through participant's last study visit, or the date of DSMB decision to unblind all participants, whichever is first. Assessed at each visit. (Injection visits q 8 weeks and safety visits q 8 weeks) | Inappropriately enrolled participants, participants with invalid ID due to duplicate screening or enrollment and participants who did not receive any oral study drug are excluded. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Resistance Mutations to Study Products (Including But Not Limited to K65R, M184V/I, Q148R) Among Seroconverters | Measured from date of detection of infection, up to 4 years after study entry, with timing/intervals as determined by the HPTN laboratory center | All participants in the mITT population who acquired HIV, including those who were found to have acquired HIV prior to randomization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Changes in Weight From Baseline | Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Collected at each injection visit (every 8 weeks). | Enrolled participants with available data at each visit | Kg | MEDIAN |
| SECONDARY | Changes in Systolic Blood Pressure From Baseline | Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each injection visit (every 8 weeks). | Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled. | mmHg | MEDIAN |
| SECONDARY | Changes in Diastolic Blood Pressure From Baseline | Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each injection visit (every 8 weeks). | Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled. | mmHg | MEDIAN |
| SECONDARY | Changes in Pulse Rate From Baseline | Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each injection visit (every 8 weeks). | Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled. | beats/min | MEDIAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group392
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Documented Incident HIV Infections During Steps 1 and 2 | Cabotegravir | 13 | Participants | ||
| Number of Participants With Documented Incident HIV Infections During Steps 1 and 2 | TDF/FTC | 39 | Participants | ||
| Number of Participants Experiencing Grade 2 or Higher Clinical and Laboratory Adverse Events | Cabotegravir | 2106 | Participants | ||
| Number of Participants Experiencing Grade 2 or Higher Clinical and Laboratory Adverse Events | TDF/FTC | 2116 | Participants | ||
| Number of Participants With Documented Incident HIV Infections in Step 2 | Cabotegravir | 8 | Participants | ||
| Number of Participants With Documented Incident HIV Infections in Step 2 | TDF/FTC | 37 | Participants | ||
| Changes From Baseline in Creatinine and Creatinine Clearance Levels | Cabotegravir | Week 57 (Injection #8) | 0.90 | Inter-Quartile Range -5.30 to 7.10 | umol/L |
| Changes From Baseline in Creatinine and Creatinine Clearance Levels | TDF/FTC | Week 57 (Injection #8) | 1.70 | Inter-Quartile Range -4.40 to 7.90 | umol/L |
| Changes From Baseline in Creatinine and Creatinine Clearance Levels | Cabotegravir | Week 105 (Injection #14) | 0.90 | Inter-Quartile Range -5.30 to 8.80 | umol/L |
| Changes From Baseline in Creatinine and Creatinine Clearance Levels | TDF/FTC | Week 105 (Injection #14) | 2.30 | Inter-Quartile Range -3.50 to 8.80 | umol/L |
1 to 10 of 392Source ClinicalTrials.gov
See all 392 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cabotegravir | 2,283 | |
| Overall Study | STARTED | TDF/FTC | 2,287 | |
| Overall Study | Ongoing | Cabotegravir | 2,210 | |
| Overall Study | Ongoing | TDF/FTC | 2,203 | |
| Overall Study | Terminated From the Study | Cabotegravir | 67 | |
| Overall Study | Terminated From the Study | TDF/FTC | 78 | |
| Overall Study | COMPLETED | Cabotegravir | 7 | |
| Overall Study | COMPLETED | TDF/FTC | 6 | |
| Overall Study | NOT COMPLETED | Cabotegravir | 2,276 | |
| Overall Study | NOT COMPLETED | TDF/FTC | 2,281 |
Source ClinicalTrials.gov
Adverse events2,440
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 | Anaemia | Blood and lymphatic system disorders | Cabotegravir | 0 | 2,281 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | TDF/FTC | 1 | 2,285 | 1 |
| other | Antiphospholipid syndrome | Blood and lymphatic system disorders | Cabotegravir | 0 | 2,281 | 0 |
| other | Antiphospholipid syndrome | Blood and lymphatic system disorders | TDF/FTC | 1 | 2,285 | 1 |
| other | Any Event in SOC | Blood and lymphatic system disorders | Cabotegravir | 33 | 2,281 | 36 |
| other | Any Event in SOC | Blood and lymphatic system disorders | TDF/FTC | 35 | 2,285 | 40 |
| other | Cyclic neutropenia | Blood and lymphatic system disorders | Cabotegravir | 1 | 2,281 | 1 |
| other | Cyclic neutropenia | Blood and lymphatic system disorders | TDF/FTC | 0 | 2,285 | 0 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Cabotegravir | 3 | 2,281 | 3 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | TDF/FTC | 0 | 2,285 | 0 |
1 to 10 of 2,440Source ClinicalTrials.gov
See all 2,440 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cabotegravir | 4 | 2,281 |
| Total, all-cause mortality | TDF/FTC | 7 | 2,285 |
| Total, other adverse events | Cabotegravir | 2,103 | 2,281 |
| Total, other adverse events | TDF/FTC | 2,114 | 2,285 |
| Total, serious adverse events | Cabotegravir | 117 | 2,281 |
| Total, serious adverse events | TDF/FTC | 109 | 2,285 |
Source ClinicalTrials.gov
Papers7
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cabotegravir vs TDF/FTC: Number of Participants With Documented Incident HIV Infections in Step 2 | Trial comparisons |
| Cabotegravir vs TDF/FTC: Number of Participants Experiencing Grade 2 or Higher Clinical and Laboratory Adverse Events | Trial comparisons |
| Cabotegravir vs TDF/FTC: Number of Participants With Grade 3 or 4 Liver-related Adverse Events (AEs) | Trial comparisons |
| Cabotegravir vs TDF/FTC: Number of Participants With Documented Incident HIV Infections During Steps 1 and 2 | Trial comparisons |
| Cabotegravir vs TDF/FTC: deaths from any cause | Trial comparisons |
| Cabotegravir vs TDF/FTC: serious adverse events | Trial comparisons |
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02720094
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