Trial · NCT03164564
Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women
NCT03164564, Phase 3, Active not recruiting, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2023-03-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women. Trials, record NCT03164564. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03164564
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women
- NCT number
- NCT03164564
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 3,224 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- HIV Infections
- Interventions
- Oral CAB, Oral TDF/FTC, Placebo for oral CAB, Placebo for oral TDF/FTC, CAB LA, Placebo for CAB LA
- First posted
- 2017-05-23
- Last updated
- 2025-10-09
- Results first posted
- 2023-03-28
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Pariicipants With Documented Incident HIV Infections | HIV tests at enrollment, weeks 2, 4, and 5, then every 4 weeks through week 25, then every 8 weeks. Analyzed through week 185 or the date of DSMB decision to unblind all participants, whichever is earliest. | The number of participants with an incident HIV infection that is confirmed by the HPTN Laboratory Center and Endpoint Adjudication Committee. |
| Primary | Number of Participants Who Experienced Grade 2 or Higher Clinical and Laboratory Adverse Events (AEs) in Steps 1 and 2 | 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) | AEs will be summarized using MedDRA System Organ Class and preferred terms. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Pariicipants With Documented Incident HIV Infections | HIV tests at enrollment, weeks 2, 4, and 5, then every 4 weeks through week 25, then every 8 weeks. Analyzed through week 185 or the date of DSMB decision to unblind all participants, whichever is earliest. | All enrolled participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Experienced Grade 2 or Higher Clinical and Laboratory Adverse Events (AEs) in Steps 1 and 2 | 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) | All enrolled participants | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Pariicipants With Documented Incident HIV Infections | Arm A: CAB + Placebo TDF/FTC + CAB LA | 4 | Participants | ||
| Number of Pariicipants With Documented Incident HIV Infections | Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA | 36 | Participants | ||
| Number of Participants Who Experienced Grade 2 or Higher Clinical and Laboratory Adverse Events (AEs) in Steps 1 and 2 | Arm A: CAB + Placebo TDF/FTC + CAB LA | 1487 | Participants | ||
| Number of Participants Who Experienced Grade 2 or Higher Clinical and Laboratory Adverse Events (AEs) in Steps 1 and 2 | Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA | 1486 | Participants |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: CAB + Placebo TDF/FTC + CAB LA | 1,614 | |
| Overall Study | STARTED | Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA | 1,610 | |
| Overall Study | Ongoing | Arm A: CAB + Placebo TDF/FTC + CAB LA | 1,586 | |
| Overall Study | Ongoing | Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA | 1,586 | |
| Overall Study | Terminated From the Study | Arm A: CAB + Placebo TDF/FTC + CAB LA | 25 | |
| Overall Study | Terminated From the Study | Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA | 17 | |
| Overall Study | COMPLETED | Arm A: CAB + Placebo TDF/FTC + CAB LA | 3 | |
| Overall Study | COMPLETED | Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA | 7 | |
| Overall Study | NOT COMPLETED | Arm A: CAB + Placebo TDF/FTC + CAB LA | 1,611 | |
| Overall Study | NOT COMPLETED | Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA | 1,603 |
Source ClinicalTrials.gov
Adverse events1,380
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 | Arm A: CAB + Placebo TDF/FTC + CAB LA | 3 | 1,614 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA | 5 | 1,610 | 5 |
| other | Any Event in SOC | Blood and lymphatic system disorders | Arm A: CAB + Placebo TDF/FTC + CAB LA | 40 | 1,614 | 54 |
| other | Any Event in SOC | Blood and lymphatic system disorders | Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA | 27 | 1,610 | 28 |
| other | Eosinophilia | Blood and lymphatic system disorders | Arm A: CAB + Placebo TDF/FTC + CAB LA | 1 | 1,614 | 1 |
| other | Eosinophilia | Blood and lymphatic system disorders | Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA | 0 | 1,610 | 0 |
| other | Hypochromic anaemia | Blood and lymphatic system disorders | Arm A: CAB + Placebo TDF/FTC + CAB LA | 2 | 1,614 | 3 |
| other | Hypochromic anaemia | Blood and lymphatic system disorders | Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA | 2 | 1,610 | 2 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Arm A: CAB + Placebo TDF/FTC + CAB LA | 4 | 1,614 | 7 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA | 3 | 1,610 | 4 |
1 to 10 of 1,380Source ClinicalTrials.gov
See all 1,380 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: CAB + Placebo TDF/FTC + CAB LA | 3 | 1,614 |
| Total, all-cause mortality | Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA | 0 | 1,610 |
| Total, other adverse events | Arm A: CAB + Placebo TDF/FTC + CAB LA | 1,486 | 1,614 |
| Total, other adverse events | Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA | 1,486 | 1,610 |
| Total, serious adverse events | Arm A: CAB + Placebo TDF/FTC + CAB LA | 33 | 1,614 |
| Total, serious adverse events | Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA | 33 | 1,610 |
Source ClinicalTrials.gov
Papers3
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Arm A: CAB + Placebo TDF/FTC + CAB LA vs Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA: Number of Participants Who Experienced Grade 2 or Higher Clinical and Laboratory Adverse Events (AEs) in Steps 1 and 2 | Trial comparisons |
| Arm A: CAB + Placebo TDF/FTC + CAB LA vs Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA: Number of Pariicipants With Documented Incident HIV Infections | Trial comparisons |
| Arm A: CAB + Placebo TDF/FTC + CAB LA vs Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA: deaths from any cause | Trial comparisons |
| Arm A: CAB + Placebo TDF/FTC + CAB LA vs Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA: 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/NCT03164564
GET https://conductscience.org/api/trials/v1/NCT03164564/events?page=2