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

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Cimetidine


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cimetidine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cimetidine, Acquired Immunodeficiency Syndrome, AIDS-Related Complex