Comparison · NCT02831764-c8a988bc
DTG + 3TC - Double-blind Phase + Open-label Phase vs DTG + TDF/FTC - Double-blind Phase + Open-label Phase: Number of Participants Who Discontinue Treatment Due to AEs Over Week 144
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. DTG + 3TC - Double-blind Phase + Open-label Phase vs DTG + TDF/FTC - Double-blind Phase + Open-label Phase: Number of Participants Who Discontinue Treatment Due to AEs Over Week 144. Trial comparisons, record NCT02831764-c8a988bc. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02831764-c8a988bc
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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 | 0.0361 | 0.0212 | 0.0608 | wilson | |
| Risk in group 2 | 0.0446 | 0.0276 | 0.0712 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00846 | -0.0389 | 0.0215 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.81 | 0.396 | 1.66 | log | |
| Odds ratio, group 1 over group 2 | 0.803 | 0.381 | 1.69 | log | |
| Number needed to treat, for one fewer participant with the outcome on DTG + 3TC - Double-blind Phase + Open-label Phase than on DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 118 | 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 | DTG + 3TC - Double-blind Phase + Open-label Phase | Participants received a two-drug regimen of DTG + 3TC administered orally, once daily until Week 96 in double-blind phase and participants continued to receive DTG + 3TC from Week 96 to Week 148 in an open-label phase. | 13 | 360 | OG000 |
| Group 2 | DTG + TDF/FTC - Double-blind Phase + Open-label Phase | Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily until Week 96 in double-blind phase and participants continued to receive DTG + TDF/FTC FDC from Week 96 to Week 148 in an open-label phase. | 16 | 359 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Who Discontinue Treatment Due to AEs Over Week 144
- Description
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants who discontinued treatment due to AEs have been reported.
- Time frame
- Up to Week 144
- Population
- Safety Population.
Source ClinicalTrials.gov
Trial
- Title
- An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir (DTG) Plus Lamivudine (3TC) With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Participants (Gemini 2)
- NCT number
- NCT02831764
- Phases
- PHASE3
- Conditions
- Infection, Human Immunodeficiency Virus, HIV Infections
- Interventions
- Dolutegravir (DTG), Lamivudine (3TC), Tenofovir disoproxil fumarate/Emtricitabine (TDF/FTC FDC)
- Lead sponsor
- ViiV Healthcare
- Results first posted
- 2019-04-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02831764?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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