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.
- 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
Patients must have:
- 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.
- 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.
- Antiviral and immunomodulating drugs, provided patient has been on such therapy for
at least 2 months prior to study entry.
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
- 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.
- Warfarin (Coumadin).
Excluded within 4 weeks prior to study entry:
- cimetidine (Tagamet), ranitidine (Zantac), famotidine (Pepcid), and nizatidine