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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002048
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

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.

Condition or disease Intervention/treatment Phase
Lymphatic Disease HIV Infections Drug: Zidovudine Not Applicable

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
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)

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Zidovudine

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:


  • 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:


- 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002048

  Hide Study Locations
United States, California
LaJolla Veterans Administration Med Ctr
LaJolla, California, United States, 92037
AIDS Clinical Trials Group
San Diego, California, United States, 92103
United States, District of Columbia
Georgetown Univ Med Ctr
Washington, District of Columbia, United States, 20007
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
Univ of South Florida
Tampa, Florida, United States, 33612
United States, Georgia
Emory Univ School of Medicine
Atlanta, Georgia, United States, 30303
United States, New Mexico
Univ of New Mexico Hlth Sciences Ctr / Dept of Med
Albuquerque, New Mexico, United States, 87131
United States, New York
Northshore Hosp / Cornell Univ
Manhasset, New York, United States, 11030
United States, North Carolina
Nalle Clinic
Charlotte, North Carolina, United States, 28207
Bowman Gray School of Medicine / North Carolina Baptist Hosp
Winston Salem, North Carolina, United States, 27103
United States, Oregon
Oregon Health Sciences Univ
Portland, Oregon, United States, 97201
Good Samaritan Hosp
Portland, Oregon, United States, 972103079
United States, Pennsylvania
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States, 19107
Graduate Hosp
Philadelphia, Pennsylvania, United States, 19146
United States, South Carolina
Med Univ of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Regional Med Ctr at Memphis
Memphis, Tennessee, United States, 38103
United States, Texas
Univ TX Galveston Med Branch
Galveston, Texas, United States, 77550
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Utah
Dr Kristen Reis
Salt Lake City, Utah, United States, 84132
Univ of Utah School of Medicine
Salt Lake City, Utah, United States, 84132
United States, Virginia
Med College of Virginia
Richmond, Virginia, United States, 23298
United States, Wisconsin
Milwaukee County Med Complex
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Glaxo Wellcome Identifier: NCT00002048     History of Changes
Other Study ID Numbers: 014J
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: September 1989

Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
HIV Infections
Lymphatic Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents