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The main objective of the study was to evaluate the antiviral activity of tenofovir disoproxil fumarate (tenofovir DF) monotherapy versus emtricitabine (FTC) plus tenofovir DF combination therapy for the treatment of chronic hepatitis B (HBV) in participants in the immune tolerant phase of HBV infection.
The efficacy of tenofovir DF monotherapy versus FTC plus tenofovir DF combination therapy was evaluated for suppression of the virus (decrease in HBV DNA), serological response (generation of antibodies to the virus), biochemical response (changes in liver enzymes), and the development of drug-resistant mutations. The safety and tolerability of both tenofovir DF monotherapy and FTC plus tenofovir DF were evaluated by routine monitoring for adverse events and changes in laboratory parameters.
Participants were randomized in a 1:1 ratio to receive tenofovir DF monotherapy or FTC plus tenofovir DF. All subjects were to continue on blinded study medication until the last subject reached Week 192. Participants who permanently discontinued study drug (on or before Week 192) were followed for a 24-week treatment-free follow-up period, or until initiation of alternative HBV therapy, whichever occurred first. Subjects who discontinued study drug on or after Week 48 because of hepatitis B surface antigen (HBsAg) loss or seroconversion to antibody to hepatitis B surface antigen (anti-HBs), however, were to have returned for their regularly scheduled through Week 192 and every 16 weeks thereafter until the last subject reached Week 192.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenofovir DF | Experimental | Participants were randomized to receive tenofovir DF plus placebo to match FTC once daily. |
|
| FTC+Tenofovir DF | Experimental | Participants were randomized to receive FTC plus tenofovir DF once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir DF | Drug | Tenofovir disoproxil fumarate (tenofovir DF) 300 mg tablet taken orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HBV DNA < 400 Copies/mL at Week 192 | The percentage of participants with HBV DNA < 400 copies/mL at Week 192 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation. | Week 192 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, and 144 | The percentage of participants with HBV DNA < 400 copies/mL at Weeks 48, 96, and 144 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation. | Weeks 48, 96, and 144 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | 90048 | United States | |||
309 participants were screened and 129 were randomized; 126 randomized participants received at least one dose of study drug, and comprise the Safety Analysis Set and the Full Analysis Set.
Participants were enrolled at 34 sites in the North America, Europe, Asia, Australia, and New Zealand. The first participant was screened on 04 September 2007. The last participant observation for the Week 192 analysis was on 03 February 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tenofovir DF | Participants were randomized to receive tenofovir disoproxil fumarate (tenofovir DF; 300 mg tablet) plus placebo to match emtricitabine (FTC; tablet) orally once daily. |
| FG001 | FTC+Tenofovir DF |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
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| FTC | Drug | Emtricitabine (FTC) 200 mg capsule taken orally once daily |
|
|
| Placebo | Drug | Placebo to match FTC taken once daily |
|
| Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, and 192 |
The percentage of participants with HBV DNA < 169 copies/mL at Weeks 48, 96, 144, and 192 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation. |
| Weeks 48, 96, 144, and 192 |
| Change From Baseline in HBV DNA at Week 48 | The change from baseline in HBV DNA at Week 48 was analyzed. | Baseline to Week 48 |
| Change From Baseline in HBV DNA at Week 96 | The change from baseline in HBV DNA at Week 96 was analyzed. | Baseline to Week 96 |
| Change From Baseline in HBV DNA at Week 144 | The change from baseline in HBV DNA at Week 144 was analyzed. | Baseline to Week 144 |
| Change From Baseline in HBV DNA at Week 192 | The change from baseline in HBV DNA at Week 192 was analyzed. | Baseline to Week 192 |
| Number of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 96, 144, and 192 | Range of normal ALT was 6 to 34 U/L for females, 6 to 43 U/L for males. Participants with missing data were considered to have failed to achieve the criteria for evaluation. | Weeks 48, 96, 144, and 192 |
| Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48, 96, 144, and 192 | The number of participants with HBeAg loss at Weeks 48, 96, 144, and 192 was analyzed. Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. No statistical analysis is presented for Week 48 because no participants met the criteria at that time point. | Weeks 48, 96, 144, and 192 |
| Number of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, and 192 | The number of participants with seroconversion to anti-HBe at Weeks 48, 96, 144, and 192 was analyzed. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative to positive. No statistical analysis is presented for Week 48 because no participants met the criteria at that time point. | Weeks 48, 96, 144, and 192 |
| Number of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, and 192 | The number of participants with HBsAg loss at Weeks 48, 96, 144, and 192 was analyzed. Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. | Weeks 48, 96, 144, and 192 |
| Number of Participants With Seroconversion to Antibody to HBsAg (Anti-HBs) at Weeks 48, 96, 144, and 192 | The number of participants with seroconversion to anti-HBs at Weeks 48, 96, 144, and 192 was analyzed. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative to positive. | Weeks 48, 96, 144, and 192 |
| Occurrence of HBV Resistance Mutations | The development of HBV resistance mutations (occurrence of conserved site changes and/or polymorphic site changes) was analyzed for the overall study period (through Week 192). | Baseline to Week 192 |
| San Diego |
| California |
| 92115 |
| United States |
| San Francisco | California | 11355 | United States |
| Miami | Florida | 33136 | United States |
| Detroit | Michigan | 48202 | United States |
| Manhasset | New York | 11030 | United States |
| New York | New York | 10021 | United States |
| New York | New York | 10029-6574 | United States |
| Germantown | Tennessee | 38138 | United States |
| Seattle | Washington | 98111 | United States |
| Camperdown | New South Wales | 2050 | Australia |
| Westmead | New South Wales | 2145 | Australia |
| Heidelburg | Victoria | 3081 | Australia |
| Melbourne | Victoria | 3004 | Australia |
| Calgary | Alberta | T2N4N1 | Canada |
| Vancouver | British Columbia | V5Z1H2 | Canada |
| Toronto | Ontario | M5G 2C4 | Canada |
| Lille | 59037 | France |
| Lyon | 69288 | France |
| Strasbourg | 67091 | France |
| Berlin | 10969 | Germany |
| Berlin | 13353 | Germany |
| Düsseldorf | 40237 | Germany |
| Frankfurt | 60590 | Germany |
| Hamburg | 20251 | Germany |
| Hanover | 30623 | Germany |
| Heidelberg | 69120 | Germany |
| Herne | 44623 | Germany |
| Mainz | 55131 | Germany |
| Pokfulam | Hong Kong |
| Shatin | Hong Kong |
| Tai Po | Hong Kong |
| Grafton | Auckland | 1150 | New Zealand |
| Hamilton | New Zealand |
| Bydgoszcz | 85-030 | Poland |
| Chorzów | 41-500 | Poland |
| Warsaw | 01-201 | Poland |
| Singapore | 119074 | Singapore |
| Singapore | 529889 | Singapore |
| Kaohsiung City | 807 | Taiwan |
| Kaoshiung | 833 | Taiwan |
| Tainan | 107 | Taiwan |
| Taipei | Taiwan |
| London | NW3 2QG | United Kingdom |
| Sheffield | S10 2JF | United Kingdom |
Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
| Completed 192 Weeks of Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| 24-week Treatment-free Follow-up Period |
|
|
Participants who were randomized and treated were analyzed for baseline characteristics.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tenofovir DF | Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily. |
| BG001 | FTC+Tenofovir DF | Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | All randomized participants were analyzed for Region of Enrollment. (Tenofovir DF, n = 65; FTC+tenofovir DF, n = 64.) | Number | participants |
| |||||||||||||||
| Hepatitis B Virus (HBV) DNA | Mean | Standard Deviation | log_10 copies/mL |
| |||||||||||||||
| Alanine Aminotransferase (ALT) | Mean | Standard Deviation | U/L |
| |||||||||||||||
| Hepatitis B e Antigen (HBeAg) | Number | participants |
| ||||||||||||||||
| Antibody to HBeAg (Anti-HBe) | Number | participants |
|
| 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 | Percentage of Participants With HBV DNA < 400 Copies/mL at Week 192 | The percentage of participants with HBV DNA < 400 copies/mL at Week 192 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation. | Full Analysis Set: participants who were randomized and received at least one dose of study drug | Posted | Number | percentage of participants | Week 192 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, and 144 | The percentage of participants with HBV DNA < 400 copies/mL at Weeks 48, 96, and 144 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation. | Full Analysis Set | Posted | Number | percentage of participants | Weeks 48, 96, and 144 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, and 192 | The percentage of participants with HBV DNA < 169 copies/mL at Weeks 48, 96, 144, and 192 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation. | Full Analysis Set | Posted | Number | percentage of participants | Weeks 48, 96, 144, and 192 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HBV DNA at Week 48 | The change from baseline in HBV DNA at Week 48 was analyzed. | Participants in the Full Analysis Set with evaluable change data at Week 48 were analyzed. | Posted | Mean | Standard Deviation | log_10 copies/mL | Baseline to Week 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HBV DNA at Week 96 | The change from baseline in HBV DNA at Week 96 was analyzed. | Participants in the Full Analysis Set with evaluable change data at Week 96 were analyzed. | Posted | Mean | Standard Deviation | log_10 copies/mL | Baseline to Week 96 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HBV DNA at Week 144 | The change from baseline in HBV DNA at Week 144 was analyzed. | Participants in the Full Analysis Set with evaluable change data at Week 96 were analyzed. | Posted | Mean | Standard Deviation | log_10 copies/mL | Baseline to Week 144 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HBV DNA at Week 192 | The change from baseline in HBV DNA at Week 192 was analyzed. | Participants in the Full Analysis Set with evaluable change data at Week 96 were analyzed. | Posted | Mean | Standard Deviation | log_10 copies/mL | Baseline to Week 192 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 96, 144, and 192 | Range of normal ALT was 6 to 34 U/L for females, 6 to 43 U/L for males. Participants with missing data were considered to have failed to achieve the criteria for evaluation. | Full Analysis Set | Posted | Number | participants | Weeks 48, 96, 144, and 192 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48, 96, 144, and 192 | The number of participants with HBeAg loss at Weeks 48, 96, 144, and 192 was analyzed. Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. No statistical analysis is presented for Week 48 because no participants met the criteria at that time point. | Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed. | Posted | Number | participants | Weeks 48, 96, 144, and 192 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, and 192 | The number of participants with seroconversion to anti-HBe at Weeks 48, 96, 144, and 192 was analyzed. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative to positive. No statistical analysis is presented for Week 48 because no participants met the criteria at that time point. | Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed. | Posted | Number | participants | Weeks 48, 96, 144, and 192 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, and 192 | The number of participants with HBsAg loss at Weeks 48, 96, 144, and 192 was analyzed. Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. | Full Analysis Set | Posted | Number | participants | Weeks 48, 96, 144, and 192 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Seroconversion to Antibody to HBsAg (Anti-HBs) at Weeks 48, 96, 144, and 192 | The number of participants with seroconversion to anti-HBs at Weeks 48, 96, 144, and 192 was analyzed. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative to positive. | Full Analysis Set | Posted | Number | participants | Weeks 48, 96, 144, and 192 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Occurrence of HBV Resistance Mutations | The development of HBV resistance mutations (occurrence of conserved site changes and/or polymorphic site changes) was analyzed for the overall study period (through Week 192). | Genotyping was attempted for all participants with HBV DNA ≥ 400 copies/mL at Week 48, 96, 144, 192 and/or the early discontinuation visit, and for all participants (with HBV DNA ≥ 400 copies/mL) after Week 192 who were on study for at least 216 weeks when the last participant reached Week 192. | Posted | Number | participants | Baseline to Week 192 |
|
|
Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up.
Treatment-emergent adverse events were collected until the last participant reached Week 192.
Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tenofovir DF (Treatment Period) | Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily. Adverse events (AEs) for this reporting group are reported for the entire treatment period. | 6 | 64 | 41 | 64 | ||
| EG001 | FTC+Tenofovir DF (Treatment Period) | Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily. AEs for this reporting group are reported for the entire treatment period. | 3 | 62 | 39 | 62 | ||
| EG002 | Tenofovir DF (24-week Treatment-free Follow-up Period) | This reporting group includes participants randomized to the Tenofovir DF group who permanently discontinued study drug on or before the last subject reached Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first. AEs reported for this reporting group are those that occurred during the 24-week treatment-free follow-up period only. | 0 | 26 | 2 | 26 | ||
| EG003 | FTC+Tenofovir DF (24-week Treatment-free Follow-up Period) | This reporting group includes participants randomized to the FTC+Tenofovir DF group who permanently discontinued study drug on or before the last subject reached Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first. AEs reported for this reporting group are those that occurred during the 24-week treatment-free follow-up period only. | 0 | 29 | 7 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Hepatitis B | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (14.1) | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (14.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (14.1) | 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:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosures | Gilead Sciences, Inc. | ClinicalTrialDisclosures@gilead.com |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D000068679 | Emtricitabine |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Withdrawal by Subject |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| White |
|
| Black |
|
| Pacific Islander |
|
| Other |
|
| Canada |
|
| France |
|
| Germany |
|
| Hong Kong |
|
| New Zealand |
|
| Poland |
|
| Singapore |
|
| Taiwan |
|
| United Kingdom |
|
| United States |
|
| Positive |
|
| Positive |
|
| Missing/Unevaluable |
|
|
|
|
|
|
|
|
|
|
|
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|
|
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