The Efficacy and Safety of Retrovir in Patients Infected With HIV Who Are Asymptomatic (CDC Group II) or Have Persistent Generalized Lymphadenopathy (CDC Group III)
2 other identifiers
interventional
N/A
1 country
22
Brief Summary
To evaluate the safety and tolerance of chronic administration of Retrovir (AZT) in HIV-infected adult patients without clinical manifestations of disease. To assess the efficacy of AZT therapy in the treatment of HIV disease in these patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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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
September 1, 1989
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may not qualify if:
- Co-existing Condition:
- Patients with the following are excluded:
- Prior history of a malignancy other than cutaneous basal cell or cervical carcinomas.
- Other significant, chronic underlying medical illness which would impair study completion.
- Liver dysfunction as demonstrated by lab results.
- Laboratory evidence of compromised bone marrow function.
- Concurrent Medication:
- Excluded:
- Any other experimental agents.
- Any probenecid-containing product.
- Patients are excluded if they have a history of symptoms characteristic of CDC class I or IV including any of the following:
- Unintentional weight loss of greater than 10 lbs, or more than 10 percent of usual body weight within the last 16 weeks.
- Unexplained fever \> 38.5 degrees C on more than 14 consecutive days or on more than 15 days in the previous 30-day period.
- Unexplained diarrhea defined by = or \> 2 liquid stools per day persisting for = or \> 14 days or 15 days in any 30-day period.
- OR History of secondary infections associated with AIDS related complex (ARC) including:
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (22)
LaJolla Veterans Administration Med Ctr
La Jolla, California, 92037, United States
AIDS Clinical Trials Group
San Diego, California, 92103, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007, United States
Univ of Miami School of Medicine
Miami, Florida, 331361013, United States
Univ of South Florida
Tampa, Florida, 33612, United States
Emory Univ School of Medicine
Atlanta, Georgia, 30303, 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
Nalle Clinic
Charlotte, North Carolina, 28207, United States
Bowman Gray School of Medicine / North Carolina Baptist Hosp
Winston-Salem, North Carolina, 27103, United States
Oregon Health Sciences Univ
Portland, Oregon, 97201, United States
Good Samaritan Hosp
Portland, Oregon, 972103079, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107, United States
Graduate Hosp
Philadelphia, Pennsylvania, 19146, United States
Med Univ of South Carolina
Charleston, South Carolina, 29425, United States
Regional Med Ctr at Memphis
Memphis, Tennessee, 38103, United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Dr Kristen Reis
Salt Lake City, Utah, 84132, United States
Univ of Utah School of Medicine
Salt Lake City, Utah, 84132, United States
Med College of Virginia
Richmond, Virginia, 23298, United States
Milwaukee County Med Complex
Milwaukee, Wisconsin, 53226, 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: 1989-09