search
Back to results

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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cimetidine
Sponsored by
Community Research Initiative of New England
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Cimetidine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • CRI of New England

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Community Research Initiative of New England
search

1. Study Identification

Unique Protocol Identification Number
NCT00002092
Brief Title
A Study to Evaluate the Effect of Cimetidine on CD4 Lymphocyte Counts in HIV Infection
Official Title
A Study to Evaluate the Effect of Cimetidine on CD4 Lymphocyte Counts in HIV Infection
Study Type
Interventional

2. Study Status

Record Verification Date
March 1996
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Community Research Initiative of New England

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Cimetidine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Cimetidine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
CRI of New England
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02445
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8922801
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs