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	Treatment or Intervention
Lymphatic Disease HIV Infections	Drug: Zidovudine

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  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.

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

Study ID Numbers:  014J; 21
Record last reviewed:  September 1989
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002048
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08