Comparison · NCT03164564-4b30331c
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
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 Pariicipants With Documented Incident HIV Infections. Trial comparisons, record NCT03164564-4b30331c. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03164564-4b30331c
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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 | 0.00248 | 0.000964 | 0.00636 | wilson | |
| Risk in group 2 | 0.0224 | 0.0162 | 0.0308 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0199 | -0.0285 | -0.0126 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.111 | 0.0395 | 0.311 | log | |
| Odds ratio, group 1 over group 2 | 0.109 | 0.0386 | 0.306 | 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 | 50.3 | 35.1 | 79.4 | from the risk difference interval |
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 | 4 | 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 | 36 | 1,610 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Pariicipants With Documented Incident HIV Infections
- Description
- The number of participants with an incident HIV infection that is confirmed by the HPTN Laboratory Center and Endpoint Adjudication Committee.
- Time frame
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.
- 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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