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

NCT00002092 | Completed

• 2 other identifiers: 119A92-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Cimetidine

Interventions

Cimetidine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Community Research Initiative of New England: lead

Study Sites (1)

CRI of New England

Brookline, Massachusetts, 02445, United States

Location

Related Publications (1)

• 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. doi: 10.1093/clinids/23.5.1049.

  PMID: 8922801 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Cimetidine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1996-03

Locations

US (1)