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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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ClinicalTrials.gov Identifier: NCT00002106
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Ranitidine hydrochloride Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 104 participants
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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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): NCT00002106


Locations
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United States, California
Pacific Oaks Med Group
Sherman Oaks, California, United States, 91403
United States, Florida
Community Research Initiative
Coral Gables, Florida, United States, 33146
United States, North Carolina
Duke Univ Med Ctr
Durham, North Carolina, United States, 27710
United States, Texas
Houston Clinical Research Network
Houston, Texas, United States, 77006
Sponsors and Collaborators
Glaxo Wellcome
More Information
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Publications:

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ClinicalTrials.gov Identifier: NCT00002106    
Other Study ID Numbers: 135A
RAN-809
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: May 1994
Keywords provided by NIH AIDS Clinical Trials Information Service:
Ranitidine
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
 Immune System Diseases
Ranitidine
Ranitidine bismuth citrate
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs