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)

June 23, 2005 updated by: Glaxo Wellcome
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • LaJolla, California, United States, 92037
        • LaJolla Veterans Administration Med Ctr
      • San Diego, California, United States, 92103
        • AIDS Clinical Trials Group
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown Univ Med Ctr
    • Florida
      • Miami, Florida, United States, 331361013
        • Univ of Miami School of Medicine
      • Tampa, Florida, United States, 33612
        • Univ of South Florida
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Emory Univ School of Medicine
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Univ of New Mexico Hlth Sciences Ctr / Dept of Med
    • New York
      • Manhasset, New York, United States, 11030
        • Northshore Hosp / Cornell Univ
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Nalle Clinic
      • Winston Salem, North Carolina, United States, 27103
        • Bowman Gray School of Medicine / North Carolina Baptist Hosp
    • Oregon
      • Portland, Oregon, United States, 97201
        • Oregon Health Sciences Univ
      • Portland, Oregon, United States, 972103079
        • Good Samaritan Hosp
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19146
        • Graduate Hosp
      • Philadelphia, Pennsylvania, United States, 19107
        • Buckley Braffman Stern Med Associates
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Med Univ of South Carolina
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • Regional Med Ctr at Memphis
    • Texas
      • Galveston, Texas, United States, 77550
        • Univ TX Galveston Med Branch
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Univ of Utah School of Medicine
      • Salt Lake City, Utah, United States, 84132
        • Dr Kristen Reis
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Med College of Virginia
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Milwaukee County Med Complex

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glaxo Wellcome

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

September 1, 1989

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 014J
  • 21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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