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)

Launched by GLAXO WELLCOME · Aug 30, 2001

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility 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.