Back to resultsA Pilot Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multicenter Trial to Evaluate the Effect of Ranitidine on Immunologic Indicators in Asymptomatic HIV-1 Infected Subjects With a CD4 Cell Count Between 400-700 Cells/mm3
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ranitidine hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Ranitidine
Eligibility Criteria
Inclusion Criteria Patients must have: Asymptomatic HIV-1 infection. CD4 count of 400-700 cells/mm3. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Significant illness. Acute illness at randomization. Hemodialysis. Prior Medication: Excluded: Antiretroviral use within 60 days prior to study entry.
Sites / Locations
- Pacific Oaks Med Group
- Community Research Initiative
- Duke Univ Med Ctr
- Houston Clinical Research Network
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002106
Brief Title
A Pilot Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multicenter Trial to Evaluate the Effect of Ranitidine on Immunologic Indicators in Asymptomatic HIV-1 Infected Subjects With a CD4 Cell Count Between 400-700 Cells/mm3
Official Title
A Pilot Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multicenter Trial to Evaluate the Effect of Ranitidine on Immunologic Indicators in Asymptomatic HIV-1 Infected Subjects With a CD4 Cell Count Between 400-700 Cells/mm3
Study Type
Interventional
2. Study Status
Record Verification Date
May 1994
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
Glaxo Wellcome
4. Oversight
5. Study Description
Brief Summary
To evaluate the effect of ranitidine on immunologic indicators in asymptomatic HIV-1 infected patients with CD4 counts of 400-700 cells/mm3.
Detailed Description
Patients are randomized to receive either ranitidine or matching placebo bid for 16 weeks, with follow-up every 4 weeks through week 20.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Ranitidine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Enrollment
104 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ranitidine hydrochloride
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Patients must have:
Asymptomatic HIV-1 infection.
CD4 count of 400-700 cells/mm3.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Significant illness.
Acute illness at randomization.
Hemodialysis.
Prior Medication:
Excluded:
Antiretroviral use within 60 days prior to study entry.
Facility Information:
Facility Name
Pacific Oaks Med Group
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Community Research Initiative
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Duke Univ Med Ctr
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Houston Clinical Research Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77006
Country
United States
12. IPD Sharing Statement
Citations:
Citation
Bartlett JA, Berry PS, Bockmon KW, Stein A, Johnson J, Quinn JB, Weinhold KJ. A placebo controlled trial of ranitidine in HIV infection. Natl Conf Hum Retroviruses Relat Infect (2nd). 1995 Jan 29-Feb 2:149
Results Reference
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Learn more about this trial
A Pilot Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multicenter Trial to Evaluate the Effect of Ranitidine on Immunologic Indicators in Asymptomatic HIV-1 Infected Subjects With a CD4 Cell Count Between 400-700 Cells/mm3
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