Completed
Cidofovir Gel for Acyclovir-Unresponsive Mucocutaneous Herpes Simplex Disease in AIDS Patients
What is being tested
Cidofovir
Drug
Who is being recruted
Blood-Borne Infections+20
+ Urogenital Diseases
+ Genital Diseases
Over 13 Years
+8 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Summary
Principal SponsorGilead Sciences
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Patients receive open-label treatment with cidofovir gel.
Principal SponsorGilead Sciences
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 13 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesDNA Virus InfectionsHerpesviridae InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsOpportunistic InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSkin DiseasesSkin Diseases, InfectiousVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsSkin Diseases, ViralSkin and Connective Tissue DiseasesHerpes SimplexHIV InfectionsAIDS-Related Opportunistic Infections
Criteria
5 inclusion criteria required to participate
>= 10 day course acyclovir at 1-4 gm/day po or 15mg/kg/day IV.
At least partially external mucocutaneous HSV infection confirmed by culture of current outbreak.
Signed, informed consent from parent or legal guardian for patients less than 18 years of age.
AIDS diagnosis per CDC criteria.
Show More Criteria
3 exclusion criteria prevent from participating
Not required if there is confirmed in vitro resistance to acyclovir.
Acyclovir, valacyclovir, famciclovir, ganciclovir, foscarnet, topical trifluride, cidofovir injection or other systemic or topical drugs with anti-herpes activity.
Evidence of cervical intraepithelial neoplasia class III (CIN III) on Pap smear (Pap smear required within 6 months of starting study drug).
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 15 locations
AIDS Healthcare Foundation Labs
Los Angeles, United StatesSharp Mission Park / Med Group
Oceanside, United StatesPark Ctr for Health / Keith Vrhel
San Diego, United StatesCompleted15 Study Centers