A Study to Evaluate the Effect of Cimetidine on CD4 Lymphocyte Counts in HIV Infection

Launched by COMMUNITY RESEARCH INITIATIVE OF NEW ENGLAND · Aug 30, 2001

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Concurrent Medication:
• Allowed:
• • All FDA-approved medications, antiretrovirals, and PCP prophylaxis drugs, with the exception of warfarin (Coumadin).
• • Other self-prescribed medications available either over the counter or through buyer's clubs.
• Patients must have:
• • HIV positivity.
• NOTE:
• • Patients on an antiviral or immunomodulating drug must have received it for at least 2 months and have no intention to make clinical or therapeutic changes in the first 8 weeks (such as adding a new agent or discontinuing effective viral suppressive therapy) that may interfere with the study.
• NOTE:
• • Patients who become pregnant after enrollment will be permitted to continue on study drug but must sign an additional informed consent indicating their awareness of the issues in taking a drug with limited safety data during pregnancy.
• Prior Medication:
• Allowed:
• • Antiviral and immunomodulating drugs, provided patient has been on such therapy for at least 2 months prior to study entry.
• Exclusion Criteria:
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Known intolerance or hypersensitivity to cimetidine.
• • Evidence of active opportunistic infection or malignancy requiring high-dose systemic chemotherapy.
• • Any symptoms suggestive of concurrent illness that are not attributable to overall impairment by HIV or are not diagnosable based on the available evidence.
• • Inability to swallow tablets (gastric feeding tubes are allowed).
• • Not willing to comply with visit schedule and study procedures.
• Concurrent Medication:
• Excluded:
• • Warfarin (Coumadin).
• Prior Medication:
• Excluded within 4 weeks prior to study entry:
• • cimetidine (Tagamet), ranitidine (Zantac), famotidine (Pepcid), and nizatidine (Axid).