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)
NCT ID: NCT00002048
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
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COMPLETED
NA
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Zidovudine
Eligibility Criteria
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Exclusion Criteria
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:
* Recurrent oral candidiasis documented by morphology or by response to antifungal therapy within 3 years.
* Herpes zoster infection within 3 years.
* Oral hairy leukoplakia at any time.
* OR History of opportunistic disease fulfilling the CDC surveillance definition of AIDS.
* Signs and symptoms at baseline characteristic of acute HIV disease (CDC group I).
* Evidence of significant neurologic dysfunction as currently defined by CDC following standard neurologic screening and AIDS Dementia Assessment.
Prior Medication:
Excluded:
\- Previous treatment for greater than 3 months duration with any antiretroviral compound such as zidovudine (AZT).
Excluded within 4 weeks of study entry:
\- Treatment with any potentially myelosuppressive drug, nephrotoxic agent, or other experimental therapy.
Excluded within 3 months of study entry:
\- Antiretroviral drugs or biologic response modifiers.
Excluded within 4 months of study entry:
\- Systemic corticosteroids.
Patients must meet the following criteria:
* HIV infection demonstrated by ELISA and confirmed by Western blot.
* Signs and symptoms of HIV disease limited to those characteristic of CDC groups II (asymptomatic) and III (persistent generalized lymphadenopathy - PGL).
* Ability to give informed consent.
* Willingness to be followed by the originating medical center for the entire 3-year duration of the study.
Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.
13 Years
ALL
No
Sponsors
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Glaxo Wellcome
INDUSTRY
Locations
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LaJolla Veterans Administration Med Ctr
La Jolla, California, United States
AIDS Clinical Trials Group
San Diego, California, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, United States
Univ of Miami School of Medicine
Miami, Florida, United States
Univ of South Florida
Tampa, Florida, United States
Emory Univ School of Medicine
Atlanta, Georgia, United States
Univ of New Mexico Hlth Sciences Ctr / Dept of Med
Albuquerque, New Mexico, United States
Northshore Hosp / Cornell Univ
Manhasset, New York, United States
Nalle Clinic
Charlotte, North Carolina, United States
Bowman Gray School of Medicine / North Carolina Baptist Hosp
Winston-Salem, North Carolina, United States
Oregon Health Sciences Univ
Portland, Oregon, United States
Good Samaritan Hosp
Portland, Oregon, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States
Graduate Hosp
Philadelphia, Pennsylvania, United States
Med Univ of South Carolina
Charleston, South Carolina, United States
Regional Med Ctr at Memphis
Memphis, Tennessee, United States
Univ TX Galveston Med Branch
Galveston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Dr Kristen Reis
Salt Lake City, Utah, United States
Univ of Utah School of Medicine
Salt Lake City, Utah, United States
Med College of Virginia
Richmond, Virginia, United States
Milwaukee County Med Complex
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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21
Identifier Type: -
Identifier Source: secondary_id
014J
Identifier Type: -
Identifier Source: org_study_id