Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
valacyclovir · 2 trials · 4 indications
Measure change in HCV RNA viral load in treatment group as compared with placebo
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| Valacyclovir | EXPERIMENTAL | Valacyclovir 500 mg po bid |
| Placebo | PLACEBO_COMPARATOR | Matching placebo twice daily |
| Name | Type | Description |
|---|---|---|
| valacyclovir | DRUG | 500 mg twice-daily oral |
| matching placebo | DRUG | twice daily as per experimental drug |
| Placebo | DRUG | Placebo tablet twice daily |
Inclusion Criteria: * Greater than 18 years old, * Documented HIV-1 seropositive, * CD4 count greater than 200, * Not on HIV antiretroviral therapy, * HSV-2 seropositive as determined by Focus EIA (IN \>3.5) * Not intending to move out of the area for the duration of study participation. * Willing ...
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Valacyclovir is an investigational small molecule being studied for HIV Infection and Chronic Hepatitis C Infection. It is being developed by GSK plc (GSK). The drug is currently in Phase 2 clinical development for these infectious disease indications.
Valacyclovir is an antiviral drug that works by inhibiting viral DNA replication. It is a prodrug that is converted to acyclovir in the body, which then targets herpes simplex virus (HSV) and other herpesviruses. In the context of HIV and Hepatitis C, it is being studied for its potential to suppress HSV co-infections.
Valacyclovir is being developed by GSK plc, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with HIV and Chronic Hepatitis C infections.
Valacyclovir is in Phase 2 clinical development. It has completed one Phase 2 trial and one Phase 3 trial, both of which are finished. The drug is not yet approved by the FDA and remains investigational for the studied indications.
Valacyclovir has been studied in two completed clinical trials. NCT00378976 was a Phase 3 trial in HIV-infected men co-infected with HSV-2 in Peru, with 20 participants. NCT01580995 was a Phase 2 trial in patients with Chronic Hepatitis C, with 19 participants in the United States.
Valacyclovir is a prodrug of acyclovir, meaning it is converted into acyclovir in the body. While they are related, Valacyclovir is a distinct chemical entity with improved oral bioavailability. The drug is being studied for its potential effects on HIV and Hepatitis C through HSV suppression.