Hepatitis C Infection With HIV Co-Infection Clinical Trial
Official title:
Open-Label Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Subjects With Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-Infection
| Verified date | January 2017 |
| Source | Gilead Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with acute genotype 1 or 4 hepatitis C virus (HCV) and chronic human immunodeficiency virus (HIV)-1 co-infection.
| Status | Completed |
| Enrollment | 26 |
| Est. completion date | January 2016 |
| Est. primary completion date | January 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Key Inclusion Criteria: - Acute, untreated, hepatitis C infection, genotype 1 or 4, with an estimated duration less than 24 weeks - Confirmed HIV-1 infection - CD4 T cell count >200/µL for individuals receiving antiretroviral therapy (ART), CD4 T cell count > 500/µL at screening for individuals without ART - Use of two effective contraception methods if female of childbearing potential or sexually active male with female partner Key Exclusion Criteria: - Pregnant or nursing female or male with pregnant female partner - Chronic liver disease of a non HCV etiology - Coinfection with hepatitis B virus (HBV) - Treatment with any investigational drug or device within 60 days of the screening visit. - History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol Note: Other protocol defined Inclusion/Exclusion criteria may apply |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Gilead Sciences |
Germany, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With Sustained Virologic Response 12 Weeks After Completion of Treatment (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug. | Posttreatment Week 12 | |
| Primary | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | Up to 6 weeks | ||
| Secondary | Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Study Treatment (SVR4) | SVR4 was defined as HCV RNA < LLOQ 4 weeks after the last dose of study drug. | Posttreatment Week 4 | |
| Secondary | Percentage of Participants With HCV RNA < LLOQ on Treatment | Weeks 2, 4, and 6 | ||
| Secondary | Change From Baseline in HCV RNA at Weeks 2, 4, and 6 | Baseline; Weeks 2, 4, and 6 | ||
| Secondary | Percentage of Participants With Virologic Failure | Virologic failure was defined as: On-treatment virologic failure confirmed HCV RNA = LLOQ after having previously had HCV RNA < LLOQ, while on treatment (ie, breakthrough), confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound), HCV RNA persistently = LLOQ through end of treatment (ie, nonresponse) Relapse HCV RNA = LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement |
Up to Posttreatment Week 12 | |
| Secondary | Change in HIV RNA From Day 1 to End of Treatment as Assessed by Proportion of Participants Who Had Confirmed HIV Virologic Rebound During the Study. | Participants with HIV virologic rebound was defined as participants with at least two HIV RNA = 400 copies/mL at 2 consecutive post-baseline visits which are at least 2 weeks apart based on actual dates. | Day 1; Week 6 | |
| Secondary | Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4 | Weeks 2, 4, 6, and Posttreatment Week 4 | ||
| Secondary | Percent Change From Baseline in CD4 T-cell Count at the End of Treatment and at Posttreatment Week 4 | Baseline; Week 6; Posttreatment Week 4 |