A Study to Evaluate the Effect of Cimetidine on CD4 Lymphocyte Counts in HIV Infection
Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Cimetidine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Community Research Initiative of New England
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.
Clinical Details
Official title: A Study to Evaluate the Effect of Cimetidine on CD4 Lymphocyte Counts in HIV Infection
Study design: Endpoint Classification: Safety Study, Primary Purpose: Treatment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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).
Locations and Contacts
CRI of New England, Brookline, Massachusetts 02445, United States
Additional Information
Related publications: Cohen CJ, Hellinger JA, Day J, Salitsky N, Shevitz A, Zackin R, DeGruttola V. Lack of effect of cimetidine on lymphocyte subsets in patients infected with human immunodeficiency virus type 1. Clin Infect Dis. 1996 Nov;23(5):1049-54.
Last updated: June 23, 2005
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