CLINICAL TRIALS PROFILE FOR SORIVUDINE

Clinical Trials for Sorivudine

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00000953 ↗	Comparison of Brovavir Versus Acyclovir in the Treatment of Herpes in HIV-Infected Patients	Completed	Bristol-Myers Squibb	Phase 2	To compare the efficacy of oral sorivudine (brovavir) and oral acyclovir for the treatment of localized herpes zoster in HIV-infected patients. HIV-infected patients are at high risk for herpesvirus infections, including varicella-zoster virus ( VZV ) infections, also called shingles. Acyclovir, an approved drug, is widely used to treat VZV infections in the HIV population. Since no data from controlled studies are available to define the role of antiviral therapy for VZV infections in HIV-infected patients, a study is needed to test the relative efficacy of brovavir, an experimental antiviral drug, versus that of acyclovir.
NCT00000953 ↗	Comparison of Brovavir Versus Acyclovir in the Treatment of Herpes in HIV-Infected Patients	Completed	Glaxo Wellcome	Phase 2	To compare the efficacy of oral sorivudine (brovavir) and oral acyclovir for the treatment of localized herpes zoster in HIV-infected patients. HIV-infected patients are at high risk for herpesvirus infections, including varicella-zoster virus ( VZV ) infections, also called shingles. Acyclovir, an approved drug, is widely used to treat VZV infections in the HIV population. Since no data from controlled studies are available to define the role of antiviral therapy for VZV infections in HIV-infected patients, a study is needed to test the relative efficacy of brovavir, an experimental antiviral drug, versus that of acyclovir.
NCT00000953 ↗	Comparison of Brovavir Versus Acyclovir in the Treatment of Herpes in HIV-Infected Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	To compare the efficacy of oral sorivudine (brovavir) and oral acyclovir for the treatment of localized herpes zoster in HIV-infected patients. HIV-infected patients are at high risk for herpesvirus infections, including varicella-zoster virus ( VZV ) infections, also called shingles. Acyclovir, an approved drug, is widely used to treat VZV infections in the HIV population. Since no data from controlled studies are available to define the role of antiviral therapy for VZV infections in HIV-infected patients, a study is needed to test the relative efficacy of brovavir, an experimental antiviral drug, versus that of acyclovir.
NCT00002358 ↗	A Study of BV-araU in the Treatment of Varicella-Zoster Viral Disease (VZV) in HIV-Infected Children Who Have Not Had Success With or Who Cannot Take Other Treatments for VZV	Completed	Bristol-Myers Squibb	Phase 3	To provide oral sorivudine ( BV-araU ) to pediatric HIV-infected patients with varicella-zoster viral disease who have failed or are intolerant of alternative therapy.
NCT00113230 ↗	Neoadjuvant Chemoradiation With RHUMAB VEGF (Avastin) for Rectal Cancer	Completed	Genentech, Inc.	Phase 2	Preoperative chemoradiation leads to increased pelvic control and overall survival, but both distant and local disease control remain problematic in locally advanced rectal cancer patients. Enhancing the effect of chemotherapy and radiotherapy can increase tumor response as well as distant disease control. Patients who have complete response to therapy have increased sphincter preservation, and can possibly have more limited surgery (full thickness local excision). When combined with standard chemotherapy, bevacizumab [RHUMAB VEGF, Avastin] has been shown to improve response and median survival in patients with metastatic colorectal cancer in a recent randomized trial, has led to increased activity in preclinical studies with radiotherapy, and has been found to be very well tolerated with chemoradiation in a phase I trial conducted at the M.D. Anderson Cancer Center (MDACC) in patients with locally advanced pancreatic cancer. The hypothesis is that the addition of bevacizumab to standard chemoradiation will safely lead to increased tumor response in patients with locally advanced rectal cancer.

Clinical Trial Conditions for Sorivudine

Condition Name

Condition Name for
Intervention	Trials
HIV Infections	2
Rectal Cancer	2
Chickenpox	2
Postherpetic Neuralgia	1

Condition MeSH

Condition MeSH for
Intervention	Trials
Rectal Neoplasms	2
HIV Infections	2
Herpes Zoster	2
Chickenpox	2

Clinical Trial Locations for Sorivudine

Trials by Country

Trials by Country for
Location	Trials
United States	27

Trials by US State

Trials by US State for
Location	Trials
Texas	4
New York	2
California	2
North Carolina	2
Massachusetts	1

Clinical Trial Progress for Sorivudine

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	2
Phase 2	3
Phase 1	1

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Completed	5
Unknown status	1

Clinical Trial Sponsors for Sorivudine

Sponsor Name

Sponsor Name for
Sponsor	Trials
Genentech, Inc.	2
M.D. Anderson Cancer Center	2
Bristol-Myers Squibb	2

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	6
Other	3
NIH	2