Trial · NCT02831764
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)
NCT02831764, Phase 3, Completed, ViiV Healthcare; results first posted 2019-04-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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). Trials, record NCT02831764. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02831764
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 722 participants, actual
- Lead sponsor
- ViiV Healthcare
- Conditions
- Infection, Human Immunodeficiency Virus, HIV Infections
- Interventions
- Dolutegravir (DTG), Lamivudine (3TC), Tenofovir disoproxil fumarate/Emtricitabine (TDF/FTC FDC)
- First posted
- 2016-07-13
- Last updated
- 2023-12-07
- Other registries' IDs
- eudract:2016-000459-28
- Results first posted
- 2019-04-22
Source ClinicalTrials.gov
Registered outcomes64
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL (c/mL) at Week 48 | Week 48 | Percentage of participants with HIV-1 RNA\<50 c/mL was obtained using Food and Drug Administration (FDA) Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest. This endpoint was analyzed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights. Intent-To-Treat Exposed (ITT-E) Population was used which comprised of all randomized participants who received at least one dose of study treatment. Percentage values are rounded off. |
| Secondary | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24 | Week 24 | Percentage of participants with HIV-1 RNA\<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with CMH weights. Percentage values are rounded off. |
| Secondary | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96 | Week 96 | Percentage of participants with HIV-1 RNA\<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with CMH weights. Percentage values are rounded off. |
| Secondary | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 144 | Week 144 | Percentage of participants with HIV-1 RNA\<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with CMH weights. Percentage values are rounded off. |
| Secondary | Time to Viral Suppression (HIV-1 RNA <50 c/mL) up to Week 144 | Up to Week 144 | Time of viral suppression is defined as the first viral load value \<50 c/mL. Nonparametric Kaplan-Meier method was performed. Participants who withdrew for any reason without being suppressed were censored at date of withdrawal. Participants who have not been withdrawn and have not had viral suppression at time of the analysis were censored at last viral load date. Confidence Interval (CI) was estimated using the Brookmeyer-Crowley method. |
| Secondary | CD4+ Cell Counts at Weeks 24 and 48 | Weeks 24 and 48 | CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. |
| Secondary | CD4+ Cell Counts at Week 96 | Week 96 | CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. |
| Secondary | CD4+ Cell Counts at Week 144 | Week 144 | CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. |
| Secondary | Changes From Baseline in CD4+ Cell Counts at Week 24 and 48 | Baseline and Weeks 24, 48 | CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted least mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor. |
| Secondary | Changes From Baseline in CD4+ Cell Counts at Week 96 | Baseline and Week 96 | CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor. |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 registered outcomesOutcomes64
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL (c/mL) at Week 48 | Week 48 | ITT-E Population | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24 | Week 24 | ITT-E Population | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96 | Week 96 | ITT-E Population | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 144 | Week 144 | ITT-E Population | Percentage of participants | NUMBER |
| SECONDARY | Time to Viral Suppression (HIV-1 RNA <50 c/mL) up to Week 144 | Up to Week 144 | ITT-E Population | Days | MEDIAN |
| SECONDARY | CD4+ Cell Counts at Weeks 24 and 48 | Weeks 24 and 48 | ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | Cells/mm^3 | MEAN |
| SECONDARY | CD4+ Cell Counts at Week 96 | Week 96 | ITT-E Population. Only those participants available at the specified time points were analyzed. | Cells/mm^3 | MEAN |
| SECONDARY | CD4+ Cell Counts at Week 144 | Week 144 | ITT-E Population. Only those participants available at the specified time points were analyzed. | Cells/mm^3 | MEAN |
| SECONDARY | Changes From Baseline in CD4+ Cell Counts at Week 24 and 48 | Baseline and Weeks 24, 48 | ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | Cells/mm^3 | LEAST_SQUARES_MEAN |
| SECONDARY | Changes From Baseline in CD4+ Cell Counts at Week 96 | Baseline and Week 96 | ITT-E Population. Only those participants available at the specified time points were analyzed. | Cells/mm^3 | MEAN |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 outcomesResults by group918
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL (c/mL) at Week 48 | DTG + 3TC - Double-blind Phase | 93 | 95% Confidence Interval 90.4 to 95.7 | Percentage of participants | |
| Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL (c/mL) at Week 48 | DTG + TDF/FTC - Double-blind Phase | 94 | 95% Confidence Interval 91.4 to 96.4 | Percentage of participants | |
| Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24 | DTG + 3TC - Double-blind Phase | 94 | 95% Confidence Interval 91.4 to 96.4 | Percentage of participants | |
| Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24 | DTG + TDF/FTC - Double-blind Phase | 94 | 95% Confidence Interval 91.4 to 96.4 | Percentage of participants | |
| Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96 | DTG + 3TC - Double-blind Phase | 88 | 95% Confidence Interval 84.4 to 91.2 | Percentage of participants | |
| Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96 | DTG + TDF/FTC - Double-blind Phase | 90 | 95% Confidence Interval 86.5 to 92.8 | Percentage of participants | |
| Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 144 | DTG + 3TC - Double-blind Phase + Open-label Phase | 84 | 95% Confidence Interval 80.4 to 87.9 | Percentage of participants | |
| Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 144 | DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 84 | 95% Confidence Interval 80.6 to 88.2 | Percentage of participants | |
| Time to Viral Suppression (HIV-1 RNA <50 c/mL) up to Week 144 | DTG + 3TC - Double-blind Phase + Open-label Phase | 29.0 | Inter-Quartile Range 29.0 to 55.0 | Days | |
| Time to Viral Suppression (HIV-1 RNA <50 c/mL) up to Week 144 | DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 29.0 | Inter-Quartile Range 29.0 to 57.0 | Days |
1 to 10 of 918Source ClinicalTrials.gov
See all 918 results by groupParticipant flow50
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Phase (Day1 to Week 96) | STARTED | DTG + 3TC - Double-blind Phase | 360 | |
| Double-blind Phase (Day1 to Week 96) | STARTED | DTG + TDF/FTC - Double-blind Phase | 362 | |
| Double-blind Phase (Day1 to Week 96) | STARTED | DTG + 3TC - Open-label Phase | 0 | |
| Double-blind Phase (Day1 to Week 96) | STARTED | DTG + TDF/FTC - Open-label Phase | 0 | |
| Double-blind Phase (Day1 to Week 96) | STARTED | DTG + 3TC - Continuation Phase | 0 | |
| Double-blind Phase (Day1 to Week 96) | Intent-to-Treat Exposed | DTG + 3TC - Double-blind Phase | 360 | |
| Double-blind Phase (Day1 to Week 96) | Intent-to-Treat Exposed | DTG + TDF/FTC - Double-blind Phase | 359 | |
| Double-blind Phase (Day1 to Week 96) | Intent-to-Treat Exposed | DTG + 3TC - Open-label Phase | 0 | |
| Double-blind Phase (Day1 to Week 96) | Intent-to-Treat Exposed | DTG + TDF/FTC - Open-label Phase | 0 | |
| Double-blind Phase (Day1 to Week 96) | Intent-to-Treat Exposed | DTG + 3TC - Continuation Phase | 0 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 participant flowAdverse events474
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 | Diarrhoea | Gastrointestinal disorders | DTG + 3TC - Double-blind Phase + Open-label Phase | 49 | 360 | 55 |
| other | Diarrhoea | Gastrointestinal disorders | DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 53 | 359 | 61 |
| other | Diarrhoea | Gastrointestinal disorders | DTG + 3TC - Continuation Phase | 0 | 252 | 0 |
| other | Nasopharyngitis | Infections and infestations | DTG + 3TC - Double-blind Phase + Open-label Phase | 44 | 360 | 59 |
| other | Nasopharyngitis | Infections and infestations | DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 69 | 359 | 103 |
| other | Nasopharyngitis | Infections and infestations | DTG + 3TC - Continuation Phase | 0 | 252 | 0 |
| other | Headache | Nervous system disorders | DTG + 3TC - Double-blind Phase + Open-label Phase | 33 | 360 | 49 |
| other | Headache | Nervous system disorders | DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 44 | 359 | 60 |
| other | Headache | Nervous system disorders | DTG + 3TC - Continuation Phase | 0 | 252 | 0 |
| other | Upper respiratory tract infection | Infections and infestations | DTG + 3TC - Double-blind Phase + Open-label Phase | 47 | 360 | 75 |
1 to 10 of 474Source ClinicalTrials.gov
See all 474 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DTG + 3TC - Double-blind Phase + Open-label Phase | 2 | 360 |
| Total, all-cause mortality | DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 1 | 359 |
| Total, all-cause mortality | DTG + 3TC - Continuation Phase | 0 | 252 |
| Total, other adverse events | DTG + 3TC - Double-blind Phase + Open-label Phase | 273 | 360 |
| Total, other adverse events | DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 276 | 359 |
| Total, other adverse events | DTG + 3TC - Continuation Phase | 45 | 252 |
| Total, serious adverse events | DTG + 3TC - Double-blind Phase + Open-label Phase | 39 | 360 |
| Total, serious adverse events | DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 47 | 359 |
| Total, serious adverse events | DTG + 3TC - Continuation Phase | 9 | 252 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| 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 |
Source 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/NCT02831764
GET https://conductscience.org/api/trials/v1/NCT02831764/registered?page=2