A Dose-Frequency Trial of Oral Retrovir in Patients With AIDS or Severe ARC
2 other identifiers
interventional
N/A
1 country
11
Brief Summary
To evaluate the pharmacokinetics of Retrovir (AZT) administered orally as 1 of 3 doses in the treatment of patients with severe clinical and laboratory manifestations of HIV infection. To compare the safety and tolerance of AZT administered 2, 3, and 6 x daily to these patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
May 1, 1990
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Treatment:
- Allowed:
- Electron beam therapy to an area of less than 100 cm2.
- Patients with the following are excluded:
- Any immediately life-threatening infection or medical condition present at the time of study entry.
- Any active opportunistic or other infection requiring chronic therapy present at the time of study entry.
- Patients with Pneumocystis carinii pneumonia (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 fever \< 39 degrees C for at least 48 hours; oxygen (on room air)
- = or \> 60 mm, and arterial / alveolar gradient = or \< 30 mm.
- Kaposi's sarcoma, lymphoma, or other tumor likely to require cytotoxic chemotherapy.
- Seropositive for HIV antibody documented by any federally licensed ELISA.
- Patients must have ability to give informed consent and advanced HIV disease defined as:
- \- History of Pneumocystis carinii pneumonia (PCP) with histologic verification within 4 months of study entry.
- OR History of other opportunistic infection included in the CDC surveillance definition of AIDS (stage IV-C-1), diagnosed within 4 months of entry, but not requiring chronic suppressive therapy, and a CD4+ cell count \< 200 cells/mm3.
- OR AIDS related complex (ARC) only those patients with a CD4+ count \< 200 cells/mm3 and documentation of at least two signs or symptoms from the list below. One sign or symptom must be weight loss or candidiasis as described.
- Unexplained weight loss \> 10 percent or = or \> 15 lbs within the previous 4 months; with low weight at entry.
- +7 more criteria
You may not qualify if:
- Co-existing Condition:
- Patients with the following are excluded:
- Chronic herpes virus infection.
- Fever \> 39 degrees C at study entry.
- Known hypersensitivity to lactate and/or gelatin.
- Kaposi's sarcoma, lymphoma, or other tumor likely to require cytotoxic chemotherapy.
- Impaired renal function.
- AIDS dementia complex.
- Concurrent Medication:
- Excluded:
- Drugs which cause significant bone marrow suppression.
- Rifampin or rifampin derivatives.
- Drugs which cause significant nephrotoxicity or hepatotoxicity.
- Antiretroviral agents, including ribavirin, dideoxycytidine, dideoxyadenosine, didanosine, foscarnet, dextran sulfate, and AL-721.
- Acyclovir therapy of more than 21 days duration.
- +26 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (11)
Univ of Arizona / Health Science Ctr
Tucson, Arizona, 85724, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Cook County Hosp
Chicago, Illinois, 60612, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21205, United States
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, 64108, United States
Univ of New Mexico Hlth Sciences Ctr / Dept of Med
Albuquerque, New Mexico, 87131, United States
Northshore Hosp / Cornell Univ
Manhasset, New York, 11030, United States
Univ of Pennsylvania / HIV Clinic
Philadelphia, Pennsylvania, 19104, United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1990-05