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| Sponsor: | Glaxo Wellcome |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002084 |
Purpose
To determine the safety and efficacy of oral valacyclovir hydrochloride ( 256U87 ) compared to acyclovir in the treatment of recurrent anogenital herpes in HIV-infected patients with CD4 counts = or > 100 cells/mm3.
| Condition | Intervention |
|---|---|
|
Herpes Simplex HIV Infections |
Drug: Valacyclovir hydrochloride Drug: Acyclovir |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| Official Title: | A Comparative Trial of Valacyclovir Hydrochloride ( 256U87 ) and Acyclovir for the Suppression of Anogenital Herpes Infections in HIV-Infected Patients |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
History of hypersensitivity to acyclovir.
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Univ of South Alabama | |
| Mobile, Alabama, United States, 36604 | |
| United States, Arizona | |
| Univ of Arizona / Health Science Ctr | |
| Tucson, Arizona, United States, 85724 | |
| United States, California | |
| UCSF - San Francisco Gen Hosp | |
| San Francisco, California, United States, 94110 | |
| ViRx Inc | |
| San Francisco, California, United States, 94103 | |
| Dr Marcus Conant | |
| San Francisco, California, United States, 94115 | |
| Los Angeles County - USC Med Ctr | |
| Los Angeles, California, United States, 90033 | |
| Infectious Disease Med Group / Adult Immunology Clinic | |
| Oakland, California, United States, 94609 | |
| UCSD Med Ctr | |
| San Diego, California, United States, 92103 | |
| Combat Group | |
| Los Angeles, California, United States, 90028 | |
| San Diego Naval Hosp | |
| San Diego, California, United States, 921345000 | |
| UCI Med Ctr | |
| Orange, California, United States, 92668 | |
| United States, Connecticut | |
| West Haven Veterans Administration Med Ctr | |
| West Haven, Connecticut, United States, 06516 | |
| United States, District of Columbia | |
| Georgetown Univ Med Ctr | |
| Washington, District of Columbia, United States, 20007 | |
| Whitman - Walker Clinic | |
| Washington, District of Columbia, United States, 20009 | |
| George Washington Univ Med Ctr | |
| Washington, District of Columbia, United States, 20037 | |
| Veterans Administration Med Ctr / Regional AIDS Program | |
| Washington, District of Columbia, United States, 20422 | |
| United States, Florida | |
| Univ of South Florida | |
| St. Petersburg, Florida, United States, 33705 | |
| United States, Georgia | |
| Emory Univ School of Medicine | |
| Atlanta, Georgia, United States, 30303 | |
| AIDS Research Consortium of Atlanta | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Illinois | |
| Rush Presbyterian - Saint Luke's Med Ctr | |
| Chicago, Illinois, United States, 60612 | |
| Northwestern Memorial Hosp | |
| Chicago, Illinois, United States, 60611 | |
| United States, Indiana | |
| Infectious Diseases Research Clinic / Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| Univ of Iowa Hosp & Clinic | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kansas | |
| Univ of Kansas School of Medicine | |
| Wichita, Kansas, United States, 67214 | |
| United States, Maryland | |
| Univ of Maryland at Baltimore | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Minnesota | |
| St Paul Ramsey Med Ctr | |
| St. Paul, Minnesota, United States, 55101 | |
| United States, Mississippi | |
| Univ of Mississippi Med Ctr | |
| Jackson, Mississippi, United States, 39216 | |
| United States, Missouri | |
| Univ of Missouri at Kansas City School of Medicine | |
| Kansas City, Missouri, United States, 64108 | |
| St Louis Univ | |
| St. Louis, Missouri, United States, 63104 | |
| United States, New York | |
| Saint Vincent's Hosp and Med Ctr | |
| New York, New York, United States, 10011 | |
| Univ of Rochester Med Ctr | |
| Rochester, New York, United States, 14642 | |
| Beth Israel Med Ctr | |
| New York, New York, United States, 10003 | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| United States, Oregon | |
| Portland Veterans Adm Med Ctr / Rsch & Education Grp | |
| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
| Univ of Pittsburgh / Graduate School of Public Health | |
| Pittsburgh, Pennsylvania, United States, 15261 | |
| Buckley Braffman Stern Med Associates | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Rhode Island | |
| Roger Williams Med Ctr | |
| Providence, Rhode Island, United States, 02908 | |
| United States, Tennessee | |
| Regional Med Ctr at Memphis | |
| Memphis, Tennessee, United States, 38103 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| Baylor College of Medicine / Texas Med Ctr | |
| Houston, Texas, United States, 77030 | |
| Univ TX Galveston Med Branch | |
| Galveston, Texas, United States, 77550 | |
| Univ TX Med Branch / Ctr for Clinical Studies | |
| Nassau Bay, Texas, United States, 77058 | |
| Thomas Audetta Clinic | |
| Houston, Texas, United States, 77006 | |
| MacGregor Med Association | |
| Houston, Texas, United States, 77054 | |
| Dallas Associated Dermatologists | |
| Dallas, Texas, United States, 75246 | |
| United States, Virginia | |
| Med College of Virginia | |
| Richmond, Virginia, United States, 232980049 | |
More Information
| Study ID Numbers: | 104B, 07 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002084 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Acyclovir Acquired Immunodeficiency Syndrome AIDS-Related Complex |
Antiviral Agents Anus Diseases Herpes Genitalis |
|
Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Infection Valacyclovir Therapeutic Uses Retroviridae Infections Herpes Simplex RNA Virus Infections Immune System Diseases Skin Diseases Acquired Immunodeficiency Syndrome |
Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Herpesviridae Infections Virus Diseases Skin Diseases, Viral Skin Diseases, Infectious Acyclovir HIV Infections Sexually Transmitted Diseases Lentivirus Infections DNA Virus Infections |
