The Safety and Effectiveness of Zidovudine Plus Acyclovir in Patients With Early HIV Infection

Launched by GLAXO WELLCOME · Aug 30, 2001

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Patients must have:
• • Early AIDS related complex (ARC).
• • Willingness to be followed by the original study center for the duration of the trial (96 weeks).
• • Ability to give informed consent.
• • Patients may have associated lymphadenopathy (lymph nodes greater than or equal to 1 cm in two noncontiguous areas).
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following are excluded:
• • Concurrent neoplasms other than basal cell carcinoma of the skin or in situ carcinoma of the cervix.
• • Fever \> 102 degrees F persisting for more than 14 consecutive days or more than 15 days in a 30-day interval, present at entry.
• • Severe malabsorption (evidenced by persistent diarrhea of greater than 4 weeks duration with = or \> 6 loose stools per day accompanied by significant weight loss).
• Concurrent Medication:
• Excluded:
• • Acyclovir (ACV) therapy for chronic or recurrent herpes simplex.
• • Patients with an AIDS-defining indicator disease as outlined by the CDC surveillance definition for AIDS which includes opportunistic infections or neoplasms, HIV neurologic disease, AIDS dementia or the "wasting syndrome" are excluded.
• Prior Medication:
• Excluded within 4 weeks of study entry:
• • Any other experimental therapy.
• • Drugs which cause significant bone marrow suppression.
• • Rifampin or rifampin derivatives.
• • Cytolytic chemotherapy.
• • Drugs which cause significant nephrotoxicity or hepatotoxicity.
• • Immunomodulating agents, including steroids, interferon, Isoprinosine, immunoglobulin or interleukin 2.
• * Excluded within 8 weeks of study entry:
• • Antiretroviral agents.