Comparison · NCT03164564-15705b69
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
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. 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, record NCT03164564-15705b69. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03164564-15705b69
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.921 | 0.907 | 0.933 | wilson | |
| Risk in group 2 | 0.923 | 0.909 | 0.935 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00167 | -0.0203 | 0.0169 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.998 | 0.978 | 1.02 | log | |
| Odds ratio, group 1 over group 2 | 0.977 | 0.755 | 1.26 | log | |
| Number needed to treat, for one fewer participant with the outcome on Arm A: CAB + Placebo TDF/FTC + CAB LA than on Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA | 600 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Arm A: CAB + Placebo TDF/FTC + CAB LA | During Step 1, participants will receive daily oral CAB and oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive injections of CAB LA at two time points 4 weeks apart and every 8 weeks thereafter and daily oral TDF/FTC placebo beginning at Week 5. In Step 3, participants will receive daily TDF/FTC for up to 48 weeks, starting no later than 8 weeks after the last injection.~Oral CAB: CAB 30 mg tablet~Oral TDF/FTC: TDF/FTC 300 mg/200 mg fixed dose combination tablet~Placebo for oral TDF/FTC: Placebo tablets~CAB LA: 600 mg administered as one 3 mL (600 mg) intramuscular injection in the gluteal muscle | 1,487 | 1,614 | OG000 |
| Group 2 | Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA | During Step 1, participants will receive daily TDF/FTC and oral CAB placebo for 5 weeks. In Step 2, participants will receive daily TDF/FTC and placebo for CAB LA injections at two times points 4 weeks apart and every 8 weeks thereafter beginning at Week 5. In Step 3, participants will receive daily TDF/FTC for up to 48 weeks, starting no later than 8 weeks after the last injection.~Oral TDF/FTC: TDF/FTC 300 mg/200 mg fixed dose combination tablet~Placebo for oral CAB: Placebo tablets~Placebo for CAB LA: Administered as one 3 mL intramuscular injection in the gluteal muscle | 1,486 | 1,610 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants Who Experienced Grade 2 or Higher Clinical and Laboratory Adverse Events (AEs) in Steps 1 and 2
- Description
- AEs will be summarized using MedDRA System Organ Class and preferred terms.
- Time frame
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)
- Population
- All enrolled participants
Source ClinicalTrials.gov
Trial
- 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
- Phases
- PHASE3
- Conditions
- HIV Infections
- Interventions
- Oral CAB, Oral TDF/FTC, Placebo for oral CAB, Placebo for oral TDF/FTC, CAB LA, Placebo for CAB LA
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Results first posted
- 2023-03-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03164564?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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