A Study of Different Doses of Atevirdine Mesylate Plus Zidovudine in HIV-Positive Patients
NCT ID: NCT00002322
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
INTERVENTIONAL
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Atevirdine mesylate
Zidovudine
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Allowed:
* Primary or secondary prophylaxis for opportunistic infections.
Patients must have:
* HIV infection.
* Symptoms (currently or prior to enrollment) included in Category B or C of CDC classification, although THE FOLLOWING CURRENT ACUTE MEDICAL CONDITIONS ARE NOT ALLOWED:
* Cryptococcosis
* Pneumocystis carinii pneumonia
* Herpes zoster
* Histoplasmosis
* CMV
* Hepatic or renal disease
* Lymphoma.
* CD4 count 50 - 350 cells/mm3 within 14 days prior to study entry.
* Ongoing therapy with AZT at 500 - 600 mg total daily dose for at least 3 months prior to study entry.
* Consent of parent, guardian, or person with power of attorney if less than 18 years of age.
Exclusion Criteria
Patients with the following conditions are excluded:
* Intolerance to AZT.
* Current diagnosis of malignancy for which systemic therapy will be required during the study.
Concurrent Medication:
Excluded:
* Any other investigational drugs.
Prior Medication:
Excluded:
* Cytotoxic chemotherapy within 1 month prior to study entry.
* Prior U-87201E or any other non-nucleoside antiretroviral medications, including but not limited to nevirapine, TIBO R-82150 or TIBO R-82913, L-697639 or L-696229, U-90152S, or any protease inhibitors.
* Antiretroviral agents other than AZT within 3 months prior to study entry.
Required:
* AZT for at least 3 months prior to study entry. Present use of excessive alcohol or illicit drugs.
13 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pharmacia and Upjohn
INDUSTRY
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Los Angeles County / Health Research Assoc / Drew Med Ctr
Los Angeles, California, United States
UCI Med Ctr
Orange, California, United States
Davies Med Ctr
San Francisco, California, United States
Infectious Disease Research Institute Inc
Tampa, Florida, United States
Johns Hopkins Hosp
Baltimore, Maryland, United States
Boston City Hosp / FGH-1
Boston, Massachusetts, United States
East Orange Veterans Administration Med Ctr
East Orange, New Jersey, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States
Mem Hosp of Rhode Island
Pawtucket, Rhode Island, United States
Park Plaza Hosp
Houston, Texas, United States
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, United States
Wisconsin Community - Based Research Consortium
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
M/3330/0018
Identifier Type: -
Identifier Source: secondary_id
210A
Identifier Type: -
Identifier Source: org_study_id