Trial · NCT01263015
A Trial Comparing GSK1349572 50mg Plus Abacavir/Lamivudine Once Daily to Atripla (Also Called The SINGLE Trial)
NCT01263015, Phase 3, Completed, ViiV Healthcare; results first posted 2014-07-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Trial Comparing GSK1349572 50mg Plus Abacavir/Lamivudine Once Daily to Atripla (Also Called The SINGLE Trial). Trials, record NCT01263015. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01263015
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial Comparing GSK1349572 50mg Plus Abacavir/Lamivudine Once Daily to Atripla (Also Called The SINGLE Trial)
- NCT number
- NCT01263015
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 844 participants, actual
- Lead sponsor
- ViiV Healthcare
- Conditions
- Infection, Human Immunodeficiency Virus I
- Interventions
- Dolutegravir, Atripla, Abacavir/Lamivudine, Abacavir/Lamivudine Placebo, Dolutegravir placebo, Atripla placebo
- First posted
- 2010-12-20
- Last updated
- 2018-04-04
- Results first posted
- 2014-07-02
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Subjects Responding Based on Plasma HIV-1 RNA <50 c/mL at Week 48 | Week 48 | The percentage of participants with plasma HIV-1 RNA \<50 c/mL at Week 48 was assessed. Plasma samples were collected for the quantitative assessment of HIV-1 RNA based on the Missing, Switch, or Discontinuation equals Failure (MSDF) algorithm,as codified by the Food and Drug Administration's Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigationl product prior to the visit window) as non-responders, as well as participants who switched their concomitant antiretroviral therapy (ART) in certain scenarios. Since changes in ART were not permitted in this protocol, all such participants who changed ART were to be considered non-responders. Otherwise, virologic success or failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the visit of interest window. |
| Secondary | Time to Viral Suppression (<50 c/mL) | From Baseline until Week 144) (average of 877.4 days for DTG; average of 788.8 study days for EFV/TDF/FTC) | Viral suppression is defined as the first viral load value\<50 c/mL. The Kaplan-Meier method was used to estimate time to viral suppression, defined as the time from the first dose of study treatment until the first viral load value \<50 c/mL was reached. Participants who withdrew for any reason without having suppressed prior to the analysis were censored. |
| Secondary | Percentage of Participants With Plasma Human Immunodeficiency Virus -1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 96 and Week 144 | Week 96 and Week 144 | The percentage of participants with plasma HIV-1 RNA \<50 c/mL at Week 96 and Week 144 was assessed. Plasma samples were collected for the quantitative assessment of HIV-1 RNA based on the Missing, Switch, or Discontinuation equals Failure (MSDF) algorithm,as codified by the Food and Drug Administration's Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigationl product prior to the visit window) as non-responders, as well as participants who switched their concomitant antiretroviral therapy (ART) in certain scenarios. Since changes in ART were not permitted in this protocol, all such participants who changed ART were to be considered non-responders. Otherwise, virologic success or failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the visit of interest window. |
| Secondary | Number of Participants With a Confirmed Plasma HIV-1 RNA Level >=1000 c/mL at or After Week 16 and Before Week 24, or a Confirmed Plasma HIV-1 RNA Level >=200 c/mL at or After Week 24 | From Baseline until Week 144) (average of 877.4 days for DTG; average of 788.8 study days for EFV/TDF/FTC) | Data are presented as Kaplan Meier estimates of virologic failure (VF), defined as a confirmed plasma HIV-1 RNA level \>=1000 c/mL at or after Week 16 and before Week 24, or a confirmed plasma HIV-1 RNA level \>=200 c/mL at or after Week 24. A plasma HIV-1 RNA value was considered to be confirmed failure if a consecutive measurement satisfied the same failure criterion. The number of participants who experienced autoimmune deficiency syndrome (AIDS) Clinical Trials Group (ACTG) VFs was measured. For participants who withdrew from the study/were not documented to have reached confirmed VF at the cut off date of the Week 48 analysis, time to VF was to be censored at the planned visit week of the last measured plasma HIV-1 RNA sample. Data for participants who missed three consecutive scheduled plasma HIV-1 RNA measurements were to be censored at the planned visit week of the last assessment prior to the 3 consecutive missed visits. |
| Secondary | Change From Baseline in Plasma HIV-1 RNA at Weeks 2, 4, 8, 12, 16, 24, 32, 40,48, 60, 72, 84, 96, 108, 120, 132 and 144 | Baseline and at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144 | Blood samples were collected for the measurement of HIV-1 RNA in plasma. Changes from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants available at the indicated time points were assessed (represented by n=X, X in the category titles). |
| Secondary | Change From Baseline in CD4+ Cell Counts at Week 144 | Baseline and Week 144 | Cluster of differentiation (CD4) lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immunocompromise. The CD4 count is used to stage the patient's disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start antiretroviral therapy. Change from Baseline was calculated as the Week 144 value minus the Baseline value. The least squares mean is the estimated mean change from Baseline in CD4+ cell counts at Week 144 calculated from a repeated measures model including the following covariates: treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, treatment\*visit interaction, Baseline HIV-1 RNA\*visit interaction, and Baseline CD4+ cell count\*visit interaction. No assumptions were made about the correlations between a participant's readings of CD4+, i.e., the correlation matrix for within-participant errors is unstructured. |
| Secondary | Change From Baseline in CD4+ Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144 | Baseline and Week 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144 | CD4 lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immunocompromise. The CD4 count is used to stage the patient's disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start antiretroviral therapy. Change from Baseline was calculated as the value at Indicated visit minus the Baseline value. Only those participants available at the indicated time points were assessed (represented by n=X, X in the category titles). |
| Secondary | Number of Participants With the Indicated Post-baseline HIV-associated Conditions and Progression, Excluding Recurrences at Week 144 | From Baseline until Week 144 | Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CDC CAT A at Baseline (BS) to a CDC CAT C event (EV); CDC CAT B at BS to a CDC CAT C EV; CDC CAT C at BS to a new CDC CAT C EV; or CDC CAT A, B, or C at BS to death. |
| Secondary | Number of Participants With the Indicated Grade 1 to 4 Clinical and Hematology Toxicities at Week144 | From Baseline until Week 144 | All Grade 1 to 4 post-Baseline-emergent chemistry toxicities included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), asparate aminotransferase (AST), carbon dioxide (CO2) content/bicarbonate, cholesterol, creatine kinase (CK), creatinine, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphorus inorganic, total bilirubin, and triglycerides. All Grade 1 to 4 post-Baseline-emergent hematology toxities included hemoglobin, platelet count, total neutrophils, and white blood cell count. The Division of AIDS (DAIDS) defined toxicity grades as follows: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening; Grade 5, death. |
| Secondary | Number of Participants With the Indicated Genotypic Resistance With Virological Failure (VF) Through 144 | Through Week 144 | Whole blood samples were collected from participants to provide plasma for storage samples for potential viral genotypic and phenotypic analyses. Participants with confirmed virological failure (confirmed HIV-1 RNA \>=50 copies/mL throughout the study and/or confirmed HIV-1 RNA \>=200 copies/mL at Week 144) had plasma samples tested for HIV-1 RT genotype and HIV-1 integrase genotype from Baseline samples and from samples collected at the time of virological failure. Genotype testing was conducted at Day 1 and at the time of suspected protocol-defined virological failure (PDVF). A genotyping assessment was made of change across all amino acids within the integrase (IN)-encoding region, with particular attention paid to specific amino acid changes associated with the development of resistance to RAL, ELV, or DTG. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Subjects Responding Based on Plasma HIV-1 RNA <50 c/mL at Week 48 | Week 48 | Intent-to-Treat-Exposed (ITT-E) Population: all randomized participants who received at least one dose of study medication | Percentage of participants | NUMBER |
| SECONDARY | Time to Viral Suppression (<50 c/mL) | From Baseline until Week 144) (average of 877.4 days for DTG; average of 788.8 study days for EFV/TDF/FTC) | ITT-E Population | Days | MEDIAN |
| SECONDARY | Percentage of Participants With Plasma Human Immunodeficiency Virus -1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 96 and Week 144 | Week 96 and Week 144 | Intent-to-Treat-Exposed (ITT-E) Population: all randomized participants who received at least one dose of study medication | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With a Confirmed Plasma HIV-1 RNA Level >=1000 c/mL at or After Week 16 and Before Week 24, or a Confirmed Plasma HIV-1 RNA Level >=200 c/mL at or After Week 24 | From Baseline until Week 144) (average of 877.4 days for DTG; average of 788.8 study days for EFV/TDF/FTC) | ITT-E Population | Participants | NUMBER |
| SECONDARY | Change From Baseline in Plasma HIV-1 RNA at Weeks 2, 4, 8, 12, 16, 24, 32, 40,48, 60, 72, 84, 96, 108, 120, 132 and 144 | Baseline and at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144 | ITT-E Population | log10 copies/mL | MEAN |
| SECONDARY | Change From Baseline in CD4+ Cell Counts at Week 144 | Baseline and Week 144 | ITT-E Population | cells per millimeters cubed (cells/mm^3) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in CD4+ Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144 | Baseline and Week 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144 | ITT-E Population | cells per millimeters cubed (cells/mm^3) | MEAN |
| SECONDARY | Number of Participants With the Indicated Post-baseline HIV-associated Conditions and Progression, Excluding Recurrences at Week 144 | From Baseline until Week 144 | ITT-E Population | Participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Grade 1 to 4 Clinical and Hematology Toxicities at Week144 | From Baseline until Week 144 | Safety Population: all participants who received at least one dose of investigational product | Participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Genotypic Resistance With Virological Failure (VF) Through 144 | Through Week 144 | PDVF Genotypic Population: all participants in the ITT-E Population with available on-treatment genotypic resistance data at the time of PDVF | Participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group152
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Subjects Responding Based on Plasma HIV-1 RNA <50 c/mL at Week 48 | DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | 88 | Percentage of participants | ||
| Proportion of Subjects Responding Based on Plasma HIV-1 RNA <50 c/mL at Week 48 | EFV/TDF/FTC 600/200/300 mg Once Daily | 81 | Percentage of participants | ||
| Time to Viral Suppression (<50 c/mL) | DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | 28 | 95% Confidence Interval 28.0 to 29.0 | Days | |
| Time to Viral Suppression (<50 c/mL) | EFV/TDF/FTC 600/200/300 mg Once Daily | 84 | 95% Confidence Interval 83.0 to 84.0 | Days | |
| Percentage of Participants With Plasma Human Immunodeficiency Virus -1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 96 and Week 144 | DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | Week 96 | 77 | Percentage of participants | |
| Percentage of Participants With Plasma Human Immunodeficiency Virus -1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 96 and Week 144 | EFV/TDF/FTC 600/200/300 mg Once Daily | Week 96 | 70 | Percentage of participants | |
| Percentage of Participants With Plasma Human Immunodeficiency Virus -1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 96 and Week 144 | DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | Week 144 | 71 | Percentage of participants | |
| Percentage of Participants With Plasma Human Immunodeficiency Virus -1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 96 and Week 144 | EFV/TDF/FTC 600/200/300 mg Once Daily | Week 144 | 63 | Percentage of participants | |
| Number of Participants With a Confirmed Plasma HIV-1 RNA Level >=1000 c/mL at or After Week 16 and Before Week 24, or a Confirmed Plasma HIV-1 RNA Level >=200 c/mL at or After Week 24 | DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | ACTG virologic failures | 11 | 0.58 | Participants |
| Number of Participants With a Confirmed Plasma HIV-1 RNA Level >=1000 c/mL at or After Week 16 and Before Week 24, or a Confirmed Plasma HIV-1 RNA Level >=200 c/mL at or After Week 24 | EFV/TDF/FTC 600/200/300 mg Once Daily | ACTG virologic failures | 8 | 0.52 | Participants |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Phase: 96 Weeks Duration | STARTED | DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | 414 | |
| Double-blind Phase: 96 Weeks Duration | STARTED | EFV/TDF/FTC 600/200/300 mg Once Daily | 419 | |
| Double-blind Phase: 96 Weeks Duration | COMPLETED | DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | 342 | |
| Double-blind Phase: 96 Weeks Duration | COMPLETED | EFV/TDF/FTC 600/200/300 mg Once Daily | 310 | |
| Double-blind Phase: 96 Weeks Duration | NOT COMPLETED | DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | 72 | |
| Double-blind Phase: 96 Weeks Duration | NOT COMPLETED | EFV/TDF/FTC 600/200/300 mg Once Daily | 109 | |
| Open-label Phase: 48 Weeks Duration | STARTED | DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | 341 | |
| Open-label Phase: 48 Weeks Duration | STARTED | EFV/TDF/FTC 600/200/300 mg Once Daily | 309 | |
| Open-label Phase: 48 Weeks Duration | COMPLETED | DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | 317 | |
| Open-label Phase: 48 Weeks Duration | COMPLETED | EFV/TDF/FTC 600/200/300 mg Once Daily | 278 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events342
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 | Dizziness | Nervous system disorders | DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | 43 | 414 | |
| other | Dizziness | Nervous system disorders | EFV/TDF/FTC 600/200/300 mg Once Daily | 154 | 419 | |
| other | Headache | Nervous system disorders | DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | 67 | 414 | |
| other | Headache | Nervous system disorders | EFV/TDF/FTC 600/200/300 mg Once Daily | 64 | 419 | |
| other | Somnolence | Nervous system disorders | DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | 10 | 414 | |
| other | Somnolence | Nervous system disorders | EFV/TDF/FTC 600/200/300 mg Once Daily | 24 | 419 | |
| other | Insomnia | Psychiatric disorders | DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | 74 | 414 | |
| other | Insomnia | Psychiatric disorders | EFV/TDF/FTC 600/200/300 mg Once Daily | 52 | 419 | |
| other | Abnormal dreams | Psychiatric disorders | DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | 32 | 414 | |
| other | Abnormal dreams | Psychiatric disorders | EFV/TDF/FTC 600/200/300 mg Once Daily | 74 | 419 |
1 to 10 of 342Source ClinicalTrials.gov
See all 342 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | ||
| Total, all-cause mortality | EFV/TDF/FTC 600/200/300 mg Once Daily | ||
| Total, other adverse events | DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | 332 | 414 |
| Total, other adverse events | EFV/TDF/FTC 600/200/300 mg Once Daily | 358 | 419 |
| Total, serious adverse events | DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | 65 | 414 |
| Total, serious adverse events | EFV/TDF/FTC 600/200/300 mg Once Daily | 60 | 419 |
Source ClinicalTrials.gov
Papers2
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 50 mg Plus ABC/3TC 600/300 mg Once Daily vs EFV/TDF/FTC 600/200/300 mg Once Daily: serious adverse events |
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/NCT01263015
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