Completed
BCX-34 (Peldesine) for HIV-Infected Patients: A Placebo-Controlled Study
What is being tested
Peldesine
Drug
Who is being recruted
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+9 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Summary
Principal SponsorBioCryst Pharmaceuticals
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Patients are given either BCX-35 or placebo for 14 or 28 days. Plasma viral load will be determined at the MTD.
Principal SponsorBioCryst Pharmaceuticals
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 18 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 DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections
Criteria
4 inclusion criteria required to participate
CD4 cell count greater than or equal to 300 cells/mm3 on 3 occasions prior to protocol treatment
Documented HIV infection
Normal or non-diagnostic electrocardiogram
Plasma viral load by Roche Amplicor HIV Monitor assay greater than or equal to 2,000 RNA copies/ml and less than or equal to 50,000 RNA copies/ml on at least 2 occasions prior to protocol treatment
5 exclusion criteria prevent from participating
Concomitant therapy with other medications having primary renal excretion (other than 3TC, ddC, and d4T)
Ongoing dideoxyinosine or other antiretroviral therapy except ZDV, 3TC, ddC, d4T, saquinavir, ritonavir, indinavir, and nelfinavir within 2 weeks of study
Participation in a study of any systemic experimental drug within the last 2 months
Severe lactose intolerance
Show More Criteria
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 1 location
Saint Francis Mem Hosp / HIV Care Unit
San Francisco, United StatesOpen Saint Francis Mem Hosp / HIV Care Unit in Google MapsCompletedOne Study Center