Completed

Alternative Dosing Regimen of Oral Retrovir for AIDS or Advanced ARC Patients

What is being tested

Zidovudine

Drug

Who is being recruted

Blood-Borne Infections+14

+ Urogenital Diseases

+ Genital Diseases

Over 13 Years

+18 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

See protocol details

Summary

Principal SponsorGlaxo Wellcome

Last updated: June 24, 2005

Sourced from a government-validated database.Claim as a partner

This study focuses on individuals living with AIDS or advanced ARC, conditions caused by HIV infection. The main goal is to assess a different dosing schedule for a medication called zidovudine (AZT), which is commonly used in HIV treatment. The study aims to understand if this new dosing regimen could improve treatment for these patients, making it safer and more tolerable over a 48-week period.

NCT00002020

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 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

4 inclusion criteria required to participate

Ability to give informed consent

Advanced HIV disease or AIDS-related complex

Prophylaxis or treatment for Pneumocystis carinii pneumonia (PCP) consisting of either trimethoprim / sulfamethoxazole, aerosolized pentamidine, pyrimethamine / sulfadoxine, or dapsone allowed at the discretion of the investigator

Seropositive for HIV infection documented by any federally licensed ELISA and confirmed by Western blot

14 exclusion criteria prevent from participating

AIDS with malignant disease likely to require cytotoxic chemotherapy

Any active opportunistic or other infection requiring chronic therapy at the time of study entry. Patients with PCP may be randomized to study medication following a minimum 7-day course of therapy resulting in stabilization of their disease. Patients with stabilized disease must have a fever < 39 C for at least 48 hours, pO2 (on room air ) = or >= 60 mm, and an Arterial/alveolar gradient = or <= 30 mm

Any immediately life-threatening infection or medical condition present at the time of study entry

Any other experimental therapy

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 12 locations

Univ of Arizona / Health Science Ctr

Tucson, United StatesOpen Univ of Arizona / Health Science Ctr in Google Maps

Northwestern Univ Med School

Chicago, United States

Cook County Hosp

Chicago, United States

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, United States

Completed12 Study Centers