A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients

Sponsor

Glaxo Wellcome (Industry)

Overall Status

Completed

CT.gov ID

NCT00002000

Collaborator

(none)

Locations

Study Details

Study Description

Brief Summary

To evaluate the safety and efficacy of oral valacyclovir hydrochloride (256U87) vs. acyclovir in the treatment of recurrent anogenital herpes in HIV-infected patients (CD4 greater than or equal to 100).

Condition or Disease	Intervention/Treatment	Phase
Herpes Simplex HIV Infections	Drug: Valacyclovir hydrochloride Drug: Acyclovir	N/A

Detailed Description

Efficacy variables include the length of the episode, the time to lesion healing, the duration and severity of pain/discomfort, the duration of viral shedding, the proportion of patients with aborted episodes, the proportion of patients requiring extended therapy.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Patients must have the following:

HIV-infected individual (CD4 = or > 100) with a history of recurrent anogenital herpes.
Signed the consent form or present a signed parental consent form if below 18 years.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

Hepatic impairments as evidenced by a three-fold increase from the upper limit of normal in alanine or aspartate transaminase. Impairment of renal function as evidenced by any elevation above the upper limit of normal for serum creatinine. History of hypersensitivity to acyclovir. Malabsorption or vomiting that would, in the investigators opinion, potentially limit the retention and absorption of oral therapy.

Patients with the following are excluded:

Hepatic impairment as evidenced by a three-fold increase from the upper limit of normal in alanine or aspartate transaminase. Impairment of renal function as evidenced by any elevation above the upper limit of normal for serum creatinine.
History of hypersensitivity to acyclovir. Malabsorption or vomiting that would, in the investigator's opinion, potentially limit the retention and absorption of oral therapy.

Prior Medication:

Excluded:

Systemic antiherpes or immunomodulatory therapy within 30 days prior to entry.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of South Alabama	Mobile	Alabama	United States	36604
2	ViRx Inc	San Francisco	California	United States	94103
3	UCSF - San Francisco Gen Hosp	San Francisco	California	United States	94110
4	Denver Public Health Dept / Disease Control Services	Denver	Colorado	United States	80204
5	West Haven Veterans Administration Med Ctr	West Haven	Connecticut	United States	06516
6	Univ of South Florida	Tampa	Florida	United States	33612
7	Emory Univ School of Medicine	Atlanta	Georgia	United States	30303
8	Northwestern Memorial Hosp	Chicago	Illinois	United States	60611
9	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois	United States	60612
10	Infectious Diseases Research Clinic / Indiana Univ Hosp	Indianapolis	Indiana	United States	46202
11	Louisiana State Univ Med School	New Orleans	Louisiana	United States	701122822
12	Univ of Mississippi Med Ctr	Jackson	Mississippi	United States	39216
13	Univ of New Mexico School of Medicine	Albuquerque	New Mexico	United States	87131
14	Saint Vincent's Hosp and Med Ctr	New York	New York	United States	10011
15	Univ of Cincinnati	Cincinnati	Ohio	United States	452670560
16	Portland Veterans Adm Med Ctr / Rsch & Education Grp	Portland	Oregon	United States	97210
17	Roger Williams Med Ctr	Providence	Rhode Island	United States	02908
18	Vanderbilt School of Medicine	Nashville	Tennessee	United States	37232
19	Univ TX Galveston Med Branch	Galveston	Texas	United States	77550
20	Baylor College of Medicine	Houston	Texas	United States	77030
21	Infectious Disease Physicians Inc	Annandale	Virginia	United States	22203
22	Univ of Washington / Pacific Med Ctr	Seattle	Washington	United States	98144