Comparison · NCT02720094-ce6968c2
Cabotegravir vs TDF/FTC: Number of Participants With Documented Incident HIV Infections During 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
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ConductScience Library. Cabotegravir vs TDF/FTC: Number of Participants With Documented Incident HIV Infections During Steps 1 and 2. Trial comparisons, record NCT02720094-ce6968c2. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02720094-ce6968c2
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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 | 0.0057 | 0.00334 | 0.00973 | wilson | |
| Risk in group 2 | 0.0171 | 0.0125 | 0.0233 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0114 | -0.018 | -0.00531 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.333 | 0.178 | 0.623 | log | |
| Odds ratio, group 1 over group 2 | 0.33 | 0.176 | 0.619 | log | |
| Number needed to treat, for one fewer participant with the outcome on Cabotegravir than on TDF/FTC | 87.8 | 55.5 | 188 | 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 | Cabotegravir | In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.~Cabotegravir tablets: 30 mg tablets~TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets~TDF/FTC placebo tablets~CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter | 13 | 2,280 | OG000 |
| Group 2 | TDF/FTC | In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.~TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets~CAB placebo tablets~Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter | 39 | 2,281 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Documented Incident HIV Infections During Steps 1 and 2
- Description
- All HIV infections included in this analysis have been reviewed and confirmed by an independent, blinded Endpoint Adjudication Committee (EAC).
- Time frame
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.
- Population
- 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.
Source ClinicalTrials.gov
Trial
- Title
- Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men
- NCT number
- NCT02720094
- Phases
- PHASE2, PHASE3
- 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
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Results first posted
- 2023-11-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02720094?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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