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Last Updated: March 28, 2024

CLINICAL TRIALS PROFILE FOR VALACYCLOVIR HYDROCHLORIDE


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505(b)(2) Clinical Trials for Valacyclovir Hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT01689285 ↗ Bioequivalence Study in Healthy Volunteers of a New Paediatric Formulation of Valacyclovir Completed Radboud University Phase 1 2013-12-01 A new paediatric formulation (oral liquid) has been developed for flexible and accurate dosing of valacyclovir in children. To establish the bioavailability of this new formulation, healthy volunteers will be exposed to the new formulation and to valacyclovir tablets. The concentration of valacyclovir in their blood after exposure to the oral liquid will be measured and compared to the tablet.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Valacyclovir Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001038 ↗ A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients Completed Glaxo Wellcome Phase 3 1969-12-31 PRIMARY: To evaluate the efficacy of valacyclovir hydrochloride (BW 256U87) in the prevention of cytomegalovirus (CMV) end-organ disease in HIV/CMV co-infected patients with CD4+ lymphocytes < 100 cells/mm3. To assess the impact of BW 256U87, high-dose oral acyclovir and low-dose oral acyclovir on survival. SECONDARY: To evaluate the effect of BW 256U87 on quality of life, the safety of the drug administered concurrently with standard antiretroviral agents and other essential therapies for the treatment and prevention of opportunistic diseases, and the efficacy of BW 256U87 in suppressing activation of other herpesviruses. To evaluate serologic and virologic risk factors for the development of CMV disease, including assessment of HIV activation, and the risk of developing drug-resistant CMV, HSV, and VZV. Gastrointestinal absorption of acyclovir is not high enough to prevent CMV disease in patients with advanced HIV disease, although there is evidence that high doses of the drug may extend survival. Valacyclovir, a prodrug that is rapidly converted to acyclovir after oral administration, has a higher absorption rate and may therefore provide inhibitory activity against CMV.
NCT00001038 ↗ A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 1969-12-31 PRIMARY: To evaluate the efficacy of valacyclovir hydrochloride (BW 256U87) in the prevention of cytomegalovirus (CMV) end-organ disease in HIV/CMV co-infected patients with CD4+ lymphocytes < 100 cells/mm3. To assess the impact of BW 256U87, high-dose oral acyclovir and low-dose oral acyclovir on survival. SECONDARY: To evaluate the effect of BW 256U87 on quality of life, the safety of the drug administered concurrently with standard antiretroviral agents and other essential therapies for the treatment and prevention of opportunistic diseases, and the efficacy of BW 256U87 in suppressing activation of other herpesviruses. To evaluate serologic and virologic risk factors for the development of CMV disease, including assessment of HIV activation, and the risk of developing drug-resistant CMV, HSV, and VZV. Gastrointestinal absorption of acyclovir is not high enough to prevent CMV disease in patients with advanced HIV disease, although there is evidence that high doses of the drug may extend survival. Valacyclovir, a prodrug that is rapidly converted to acyclovir after oral administration, has a higher absorption rate and may therefore provide inhibitory activity against CMV.
NCT00001054 ↗ The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children Withdrawn Glaxo Wellcome Phase 1 1969-12-31 To obtain tolerance, safety, and pharmacokinetic data for oral valacyclovir hydrochloride ( 256U87 ) in HIV-1 infected children with herpes simplex virus infections ( cold sores ) and/or varicella / zoster virus infections ( chicken pox / shingles ). Varicella and zoster are common problems in HIV-infected children. It is believed that chronic oral therapy with acyclovir may result in subtherapeutic concentrations of acyclovir, resulting in resistance to that drug. Valacyclovir hydrochloride, which converts to acyclovir in the body, increases acyclovir bioavailability by 3-5 fold.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Valacyclovir Hydrochloride

Condition Name

Condition Name for Valacyclovir Hydrochloride
Intervention Trials
HIV Infections 13
Herpes Simplex 13
Herpes Zoster 10
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Condition MeSH

Condition MeSH for Valacyclovir Hydrochloride
Intervention Trials
Herpes Simplex 31
Infection 20
Infections 19
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Clinical Trial Locations for Valacyclovir Hydrochloride

Trials by Country

Trials by Country for Valacyclovir Hydrochloride
Location Trials
United States 300
Canada 28
India 5
France 4
United Kingdom 3
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Trials by US State

Trials by US State for Valacyclovir Hydrochloride
Location Trials
Texas 37
California 17
Washington 14
Pennsylvania 13
Maryland 13
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Clinical Trial Progress for Valacyclovir Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Valacyclovir Hydrochloride
Clinical Trial Phase Trials
Phase 4 18
Phase 3 11
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Valacyclovir Hydrochloride
Clinical Trial Phase Trials
Completed 73
Recruiting 16
Terminated 9
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Clinical Trial Sponsors for Valacyclovir Hydrochloride

Sponsor Name

Sponsor Name for Valacyclovir Hydrochloride
Sponsor Trials
GlaxoSmithKline 11
M.D. Anderson Cancer Center 11
University of Washington 10
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Sponsor Type

Sponsor Type for Valacyclovir Hydrochloride
Sponsor Trials
Other 134
Industry 75
NIH 17
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