A Study to Evaluate the Effect of Cimetidine on CD4 Lymphocyte Counts in HIV Infection
Not Applicable
Completed
- Conditions
- HIV Infections
- Registration Number
- NCT00002092
- Lead Sponsor
- Community Research Initiative of New England
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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.
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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).
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CRI of New England
🇺🇸Brookline, Massachusetts, United States