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



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

For Condition: HIV Infections
Status: Completed
Sponsor(s): Community Research Initiative of New England ,
Synopsis: 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.
Details:
Eligibility:
Study Type:  Interventional, Treatment, Placebo Control, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 nazitidine (Azid).
Total Enrollment: 

Location and Contact Information:

CRI of New England
Brookline,  Massachusetts,  02445
United States
 


Additional Information:
Study ID Numbers:  119A;  92-01
Study Start Date: 
Record last reviewed: March 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002092

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