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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002092
First Posted: August 31, 2001
Last Update Posted: March 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  Purpose
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.

Condition Intervention
HIV Infections Drug: Cimetidine

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Study to Evaluate the Effect of Cimetidine on CD4 Lymphocyte Counts in HIV Infection

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002092


Locations
United States, Massachusetts
CRI of New England
Brookline, Massachusetts, United States, 02445
Sponsors and Collaborators
Community Research Initiative of New England
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00002092     History of Changes
Other Study ID Numbers: 119A
92-01
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: March 17, 2014
Last Verified: March 1996

Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Cimetidine

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Cimetidine
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors