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The objective of this study is to provide open label emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for an additional 5 years (240 weeks) to adults completing study GS-US-203-0107.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FTC/TDF | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FTC/TDF | Drug | 200/300 mg tablet administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had Access to, and Received the Intervention | This endpoint has been included to satisfy the requirements of ClinicalTrials.gov. However, there were no prespecified endpoints in this study. | Up to 240 weeks |
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Key Inclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | 90048 | United States | |||
51 participants were screened.
Participants were enrolled at study sites in the US. The first participant was screened on 06 Aug 2009. The last study visit occurred on 20 November 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | FTC/TDF | Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF, Truvada®) (200/300 mg) fixed dose combination (FDC) tablet administered once daily for up to 240 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full Analysis Set: participants who were enrolled into the study and received study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | FTC/TDF | FTC/TDF (200/300 mg) FDC tablet administered once daily for up to 240 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Had Access to, and Received the Intervention | This endpoint has been included to satisfy the requirements of ClinicalTrials.gov. However, there were no prespecified endpoints in this study. | Participants who were enrolled into the study and received study drug. | Posted | Count of Participants | Participants | Up to 240 weeks |
|
|
Up to 240 weeks plus 30 days
Non serious/other adverse events were not collected per study protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FTC/TDF | FTC/TDF (200/300 mg) FDC tablet administered orally once daily for up to 240 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bile duct obstruction Hepatobiliary disorders | Hepatobiliary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosures | Gilead Sciences | ClinicalTrialDisclosures@gilead.com |
Not provided
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| San Francisco |
| California |
| 94115 |
| United States |
| Miami | Florida | 33136 | United States |
| New York | New York | 10016 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
|
| 7 |
| 24 |
| 0 |
| 0 |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Anal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Hepatic cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Metastatic gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Bipolar disorder | Psychiatric disorders | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | Systematic Assessment |
|
| Appendicectomy | Surgical and medical procedures | Systematic Assessment |
|
| Lung lobectomy | Surgical and medical procedures | Systematic Assessment |
|
| Blood pressure inadequately controlled | Vascular disorders | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000068679 |
| Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |