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A Study to Evaluate the Effect of Cimetidine on CD4 Lymphocyte Counts in HIV Infection
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsored by: Community Research Initiative of New England
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002092
  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: Treatment, Placebo Control, Safety Study
Official Title: A Study to Evaluate the Effect of Cimetidine on CD4 Lymphocyte Counts in HIV Infection

Resource links provided by NLM:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Study ID Numbers: 119A, 92-01
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002092     History of Changes
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Neurotransmitter Agents
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Immunologic Deficiency Syndromes
Histamine H2 Antagonists
Histamine
Virus Diseases
Histamine Antagonists
HIV Infections
Sexually Transmitted Diseases
Histamine phosphate
Retroviridae Infections
Cimetidine

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

ClinicalTrials.gov processed this record on July 02, 2009