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)
Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphatic Disease; HIV Infections
Intervention: Zidovudine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Glaxo Wellcome
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.
Clinical Details
Official title: 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)
Study design: Primary Purpose: Treatment
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Exclusion Criteria
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:
- 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.
Locations and Contacts
LaJolla Veterans Administration Med Ctr, LaJolla, California 92037, United States
AIDS Clinical Trials Group, San Diego, California 92103, United States
Georgetown Univ Med Ctr, Washington, 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
Good Samaritan Hosp, Portland, Oregon 972103079, United States
Oregon Health Sciences Univ, Portland, Oregon 97201, 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
Additional Information
Last updated: June 23, 2005
|