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)

Completed · Not applicable

Conditions studied: Lymphatic Disease, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002048

Run by

Glaxo Wellcome

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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:

Where it is running

• Med College of Virginia — Richmond, Virginia, United States
• Milwaukee County Med Complex — Milwaukee, Wisconsin, United States
• 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

Full record on ClinicalTrials.gov

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