Completed
Safety and Tolerance of Retrovir Capsules in HIV-Infected Patients with Renal Failure
What is being tested
Zidovudine
Drug
Who is being recruted
Blood-Borne Infections+26
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+15 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Summary
Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
This study focuses on HIV-infected individuals who are also experiencing renal failure and are on regular hemodialysis. The main goal is to understand how well a medication called Retrovir, also known as AZT, works and is tolerated in these specific circumstances. The importance of this study lies in the potential to improve treatment options for HIV patients with renal failure, a group with unique medical needs.
Principal SponsorGlaxo Wellcome
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 DiseasesChronic DiseaseCommunicable DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsKidney DiseasesPathologic ProcessesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesPathological Conditions, Signs and SymptomsUrologic DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsDisease AttributesRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital DiseasesAcquired Immunodeficiency SyndromeAIDS-Related ComplexKidney Failure, ChronicHIV Infections
Criteria
8 inclusion criteria required to participate
A positive HIV antibody test (ELISA confirmed by Western blot)
Acceptable hepatic function defined by specified lab values
Chronic renal failure managed by a stable hemodialysis regimen
Life expectancy > 6 months
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7 exclusion criteria prevent from participating
Active drug or alcohol abuse
Active, serious opportunistic infections at the time of study entry
Any other experimental therapy. Drugs which cause significant bone marrow suppression. Rifampin or rifampin derivatives. Cytolytic chemotherapy. Drugs which cause significant hepatotoxicity within 2 weeks of study entry
Fever > 100 degrees F at 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 1 location
Univ of Maryland at Baltimore
Baltimore, United StatesOpen Univ of Maryland at Baltimore in Google MapsCompletedOne Study Center