NCT00002092CompletedNot Applicable
A Study to Evaluate the Effect of Cimetidine on CD4 Lymphocyte Counts in HIV Infection
Community Research Initiative of New England1 site in 1 countryStarted: August 31, 2001Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Locations
- 1
Study Overview
Brief Summary
To determine the change in CD4 count after 4 and 8 weeks in HIV-infected patients treated with cimetidine compared to placebo. To observe time-associated trends at weeks 4, 8, 12, and 16 in the change of CD4 counts for patients taking cimetidine for the full 16 weeks. To establish a safety record for cimetidine use in HIV-positive patients.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Concurrent Medication:
- •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.
- •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.
- •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:
- •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:
- •Warfarin (Coumadin).
- •Prior Medication:
- •Excluded within 4 weeks prior to study entry:
- •cimetidine (Tagamet), ranitidine (Zantac), famotidine (Pepcid), and nizatidine (Axid).
Investigators
Study Sites (1)
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