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

Sponsors

Lead sponsor: Community Research Initiative of New England

Source NIH AIDS Clinical Trials Information Service
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.

Overall Status Completed
Phase N/A
Study Type Interventional
Condition
Intervention

Intervention type: Drug

Intervention name: Cimetidine

Eligibility

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).

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Location
facility CRI of New England
Location Countries

United States

Verification Date

March 1996

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Primary purpose: Treatment

Source: ClinicalTrials.gov