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This is an open-label study evaluating multiple doses of GS-7340 versus Tenofovir disoproxil fumarate (TDF).
This is a randomized, open-label, active-controlled study whose primary objective is to evaluate the safety and efficacy of several doses of GS-7340. This study will evaluate the safety, viral kinetics, and antiviral activity of 4 different doses of GS-7340 over 28 days of therapy. In addition, the study will evaluate the antiviral activity of an optimal dose of GS-7340 versus 300mg Tenofovir disoproxil fumarate (TDF) over 28 days of therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GS-7340 8mg | Experimental | After Screening procedures, eligible subjects will be randomized 1:1:1:1:1 to receive either open-label GS-7340 8, 25, 40, or 120 mg (3 x 40 mg), or open-label TDF 300 mg for 28 days. |
|
| GS-7340 25mg | Experimental | After Screening procedures, eligible subjects will be randomized 1:1:1:1:1 to receive either open-label GS-7340 8, 25, 40, or 120 mg (3 x 40 mg), or open-label TDF 300 mg for 28 days. |
|
| GS-7340 40mg | Experimental | After Screening procedures, eligible subjects will be randomized 1:1:1:1:1 to receive either open-label GS-7340 8, 25, 40, or 120 mg (3 x 40 mg), or open-label TDF 300 mg for 28 days. |
|
| GS-7340 120mg | Experimental | After Screening procedures, eligible subjects will be randomized 1:1:1:1:1 to receive either open-label GS-7340 8, 25, 40, or 120 mg (3 x 40 mg), or open-label TDF 300 mg for 28 days. |
|
| Tenofovir disoproxil fumarate 300mg | Experimental | After Screening procedures, eligible subjects will be randomized 1:1:1:1:1 to receive either open-label GS-7340 8, 25, 40, or 120 mg (3 x 40 mg), or open-label TDF 300 mg for 28 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS-7340 | Drug | Subjects are randomized to receive one of four different doses of GS-7340 over 28 days of therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum hepatitis B virus (HBV) DNA | Time-weighted average change from baseline through Week 4 (DAVG4) in serum HBV DNA (log10 IU/mL) for GS-7340 8-, 25-, 40 and 120-mg. | Up to Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HBV DNA for tenofovir disoproxil fumarate (TDF) | Comparing the short-term antiviral activity of GS-7340 with TDF 300mg. This is measured by time-weighted average change from baseline through Week 4 (DAVG4) in serum HBV DNA (log10 IU/mL) for TDF. | Up to Week 4 |
| Change in HBV DNA of GS-7340 through 28 days of therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Flaherty, MD | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research and Education Inc. | San Diego | California | 92105 | United States | ||
| University of Maryland Institute of Human Virology |
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
18 months after study completion
A secured external environment with username, password, and RSA code.
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|
| Tenofovir disoproxil fumarate | Drug | Subjects will receive 300mg of Tenofovir disoproxil fumarate (TDF) over 28 days of therapy |
|
|
Time weighted change from baseline to day 29 (DAVG4) in serum HBV DNA (log10 IU/mL) |
| Up to week 4 |
| Pharmacokinetics (PK) of GS-7340 and/or tenofovir (TVF) following single and multiple doses of GS-7340 and TDF | GS-7340 and tenofovir (TFV) PK parameters in plasma will be calculated as applicable: Cmax, Tmax, Clast, Tlast, T1/2, λz, AUC0-t, AUC0-last, AUC0-∞, %AUCexp. PK samples are collected on:
| Up to week 4 |
| Safety and Tolerability of Therapy | Safety and tolerability is measured by the incidence of adverse events and graded laboratory abnormalities | Up to week 4 |
| Baltimore |
| Maryland |
| 21201 |
| United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Baylor College of Medicine - St. Luke's Episcopal Hospital | Houston | Texas | 77030 | United States |
| Monash Medical Centre | Melborne | Victoria | 03168 | Australia |
| Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Austin Health | Melbourne | Victoria | 3084 | Australia |
| Linear Clinical Research Ltd | Nedlands | Western Australia | 6009 | Australia |
| Downtown Infectious Diseases Clinic (University of British Columbia) | Vancouver | British Columbia | V6Z2C9 | Canada |
| The Ottawa Hospital, General Campus | Ottawa | Ontario | K1H8L6 | Canada |
| Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| Algorithme Pharma | Montreal | Quebec | H3P3P1 | Canada |
| Pro-recherche | Saint Romuald | Quebec | G6W 8H1 | Canada |
| Auckland Clinical Studies | Auckland | 1042 | New Zealand |
| University Hospitals Birmingham NHS Foundation Trust | Birmingham | B152TH | United Kingdom |
| Grahame Hayton Unit | London | E1 1BB | United Kingdom |
| University College London Hospital | London | NW1-2BU | United Kingdom |
| Institute of Liver Studies, King's College Hospital | London | SE5 9RS | United Kingdom |
| Nottingham University Hospitals NHS Trust - Queens Medical Centre | Nottingham | NG7 2UH | United Kingdom |
| 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 |
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| ID | Term |
|---|---|
| C442442 | tenofovir alafenamide |
| D000068698 | Tenofovir |
| 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 |
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