Trial · NCT00737568
Tenofovir Disoproxil Fumarate (Tenofovir DF) Versus Emtricitabine/Tenofovir DF in Subjects Resistant to Lamivudine
NCT00737568, Phase 3, Completed, Gilead Sciences; results first posted 2013-04-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tenofovir Disoproxil Fumarate (Tenofovir DF) Versus Emtricitabine/Tenofovir DF in Subjects Resistant to Lamivudine. Trials, record NCT00737568. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00737568
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tenofovir Disoproxil Fumarate (Tenofovir DF) Versus Emtricitabine/Tenofovir DF in Subjects Resistant to Lamivudine
- NCT number
- NCT00737568
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 280 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Hepatitis B
- Interventions
- TDF, FTC/TDF, TDF Placebo, FTC/TDF Placebo
- First posted
- 2008-08-19
- Last updated
- 2016-03-11
- Results first posted
- 2013-04-11
- Limitations and caveats
- There were no limitations affecting the analysis or results.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With HBV DNA < 400 Copies/mL at Week 96 | Week 96 | |
| Secondary | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 144, 192, and 240 | Weeks 48, 144, 192, and 240 | |
| Secondary | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, 192, and 240 | Weeks 48, 96, 144, 192, and 240 | |
| Secondary | HBV DNA Level at Weeks 48, 96, 144, 192, and 240 | Weeks 48, 96, 144, 192, and 240 | |
| Secondary | Percentage of Participants With Normal ALT at Weeks 48, 96, 144, 192, and 240 | Weeks 48, 96, 144, 192, and 240 | Normal ALT was defined as having a value less than or equal to the ULN. The ULN was 43 U/L for males and 34 U/L for females aged 18 to \< 69, and 35 U/L for males and 32 U/L for females aged ≥ 69. |
| Secondary | Percentage of Participants With HBeAg Loss at Weeks 48, 96, 144, 192, and 240 | Baseline; Weeks 48, 96, 144, 192, and 240 | The percentage of participants who were HBeAg positive at baseline and who had HBeAg Loss at the given time point was summarized. Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. |
| Secondary | Percentage of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, 192, and 240 | Baseline; Weeks 48, 96, 144, 192, and 240 | The percentage of participants who were HBeAg positive at baseline and who had seroconversion to anti-HBe at the given time point was summarized. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative to positive. |
| Secondary | Percentage of Participants With HBV Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, 192, and 240 | Baseline; Weeks 48, 96, 144, 192, and 240 | The percentage of participants with HBsAg Loss at the given time point was summarized. Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. |
| Secondary | Percentage of Participants With Seroconversion to Antibody Against HBV Surface Antigen (Anti-HBs) at Weeks 48, 96, 144, 192, and 240 | Baseline; Weeks 48, 96, 144, 192, and 240 | The percentage of participants with seroconversion to anti-HBs at the given time point was summarized. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative to positive. |
| Secondary | Percentage of Participants With Virologic Breakthrough at Weeks 48, 96, 144, 192, and 240 | Baseline; Weeks 48, 96, 144, 192, and 240 | The percentage of participants with virologic breakthrough at the given time point was summarized. Virologic breakthrough was defined as having two consecutive 1.0 log10 or greater increases in serum HBV DNA from on-treatment nadir, or two consecutive HBV DNA values ≥ 400 copies/mL after being \< 400 copies/mL. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
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 HBV DNA < 400 Copies/mL at Week 96 | Week 96 | Full Analysis Set: participants were randomized and received at least 1 dose of study drug. The missing = failure method was used in which participants with missing data were considered to have failed to achieve the endpoint. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 144, 192, and 240 | Weeks 48, 144, 192, and 240 | Full Analysis Set, missing = failure method | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, 192, and 240 | Weeks 48, 96, 144, 192, and 240 | Full Analysis Set, missing = failure method | percentage of participants | NUMBER |
| SECONDARY | HBV DNA Level at Weeks 48, 96, 144, 192, and 240 | Weeks 48, 96, 144, 192, and 240 | Full analysis set; participants with HBV DNA measurements at the given time point were included in the analysis. | log10 copies/mL | MEAN |
| SECONDARY | Percentage of Participants With Normal ALT at Weeks 48, 96, 144, 192, and 240 | Weeks 48, 96, 144, 192, and 240 | Full Analysis Set, missing = failure method | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HBeAg Loss at Weeks 48, 96, 144, 192, and 240 | Baseline; Weeks 48, 96, 144, 192, and 240 | Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed using the missing = failure method. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, 192, and 240 | Baseline; Weeks 48, 96, 144, 192, and 240 | Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed using the missing = failure method. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HBV Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, 192, and 240 | Baseline; Weeks 48, 96, 144, 192, and 240 | Full Analysis Set, missing = failure method | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Seroconversion to Antibody Against HBV Surface Antigen (Anti-HBs) at Weeks 48, 96, 144, 192, and 240 | Baseline; Weeks 48, 96, 144, 192, and 240 | Full Analysis Set, missing = failure method | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Virologic Breakthrough at Weeks 48, 96, 144, 192, and 240 | Baseline; Weeks 48, 96, 144, 192, and 240 | Full Analysis Set; the missing-equals-excluded method was used in which participants with missing data were excluded from the analysis. | percentage of participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group126
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 HBV DNA < 400 Copies/mL at Week 96 | Tenofovir DF | 89.4 | percentage of participants | ||
| Percentage of Participants With HBV DNA < 400 Copies/mL at Week 96 | FTC/Tenofovir DF | 86.3 | percentage of participants | ||
| Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 144, 192, and 240 | Tenofovir DF | Week 48 | 81.6 | percentage of participants | |
| Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 144, 192, and 240 | FTC/Tenofovir DF | Week 48 | 84.2 | percentage of participants | |
| Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 144, 192, and 240 | Tenofovir DF | Week 144 | 87.2 | percentage of participants | |
| Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 144, 192, and 240 | FTC/Tenofovir DF | Week 144 | 84.9 | percentage of participants | |
| Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 144, 192, and 240 | Tenofovir DF | Week 192 | 86.5 | percentage of participants | |
| Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 144, 192, and 240 | FTC/Tenofovir DF | Week 192 | 85.6 | percentage of participants | |
| Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 144, 192, and 240 | Tenofovir DF | Week 240 | 83.0 | percentage of participants | |
| Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 144, 192, and 240 | FTC/Tenofovir DF | Week 240 | 82.7 | percentage of participants |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period Through Week 240 | STARTED | Tenofovir DF | 141 | |
| Treatment Period Through Week 240 | STARTED | FTC/Tenofovir DF | 139 | |
| Treatment Period Through Week 240 | COMPLETED | Tenofovir DF | 121 | |
| Treatment Period Through Week 240 | COMPLETED | FTC/Tenofovir DF | 118 | |
| Treatment Period Through Week 240 | NOT COMPLETED | Tenofovir DF | 20 | |
| Treatment Period Through Week 240 | NOT COMPLETED | FTC/Tenofovir DF | 21 | |
| Treatment-Free Follow-up (TFFU) Period | STARTED | Tenofovir DF | 38 | |
| Treatment-Free Follow-up (TFFU) Period | STARTED | FTC/Tenofovir DF | 37 | |
| Treatment-Free Follow-up (TFFU) Period | COMPLETED | Tenofovir DF | 12 | |
| Treatment-Free Follow-up (TFFU) Period | COMPLETED | FTC/Tenofovir DF | 19 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events152
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 | Abdominal pain | Gastrointestinal disorders | Tenofovir DF | 6 | 141 | |
| other | Abdominal pain | Gastrointestinal disorders | FTC/Tenofovir DF | 7 | 139 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Tenofovir DF | 8 | 141 | |
| other | Abdominal pain upper | Gastrointestinal disorders | FTC/Tenofovir DF | 12 | 139 | |
| other | Diarrhoea | Gastrointestinal disorders | Tenofovir DF | 13 | 141 | |
| other | Diarrhoea | Gastrointestinal disorders | FTC/Tenofovir DF | 7 | 139 | |
| other | Nausea | Gastrointestinal disorders | Tenofovir DF | 12 | 141 | |
| other | Nausea | Gastrointestinal disorders | FTC/Tenofovir DF | 11 | 139 | |
| other | Fatigue | General disorders | Tenofovir DF | 14 | 141 | |
| other | Fatigue | General disorders | FTC/Tenofovir DF | 15 | 139 |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tenofovir DF | ||
| Total, all-cause mortality | FTC/Tenofovir DF | ||
| Total, other adverse events | Tenofovir DF | 109 | 141 |
| Total, other adverse events | FTC/Tenofovir DF | 105 | 139 |
| Total, serious adverse events | Tenofovir DF | 23 | 141 |
| Total, serious adverse events | FTC/Tenofovir DF | 21 | 139 |
Source ClinicalTrials.gov
Papers4
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 |
|---|
| Tenofovir DF vs FTC/Tenofovir DF: 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.
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