Completed
Two Doses of Atevirdine Mesylate and Fixed Doses of Zidovudine (AZT) in HIV+ Patients
What is being tested
Atevirdine mesylate
+ Zidovudine
Drug
Who is being recruted
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
Over 13 Years
+12 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Summary
Principal SponsorPharmacia and Upjohn
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Patients are randomized to 1 of 3 treatment groups: U-87201E at 1 of 2 doses or placebo administered every 8 hours. Patients must have taken AZT for at least 3 months prior to randomization.
Principal SponsorPharmacia and Upjohn
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 DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexHIV Infections
Criteria
6 inclusion criteria required to participate
CD4 count 50 - 350 cells/mm3 within 14 days prior to study entry
Consent of parent, guardian, or person with power of attorney if less than 18 years of age
HIV infection
Ongoing therapy with AZT at 500 - 600 mg total daily dose for at least 3 months prior to study entry
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6 exclusion criteria prevent from participating
Antiretroviral agents other than AZT within 3 months prior to study entry
Any other investigational drugs
Current diagnosis of malignancy for which systemic therapy will be required during the study
Cytotoxic chemotherapy within 1 month prior to study entry
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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 12 locations
Los Angeles County / Health Research Assoc / Drew Med Ctr
Los Angeles, United StatesOpen Los Angeles County / Health Research Assoc / Drew Med Ctr in Google MapsUCI Med Ctr
Orange, United StatesDavies Med Ctr
San Francisco, United StatesInfectious Disease Research Institute Inc
Tampa, United StatesCompleted12 Study Centers