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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002106
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
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 evaluate the effect of ranitidine on immunologic indicators in asymptomatic HIV-1 infected patients with CD4 counts of 400-700 cells/mm3.

Condition Intervention Phase
HIV Infections Drug: Ranitidine hydrochloride Phase 2

Study Type: Interventional
Study Design: 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 NLM:


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

Estimated Enrollment: 104
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.
  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

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
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
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

Publications:
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

ClinicalTrials.gov Identifier: NCT00002106     History of Changes
Other Study ID Numbers: 135A
RAN-809
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
Last Verified: May 1994

Keywords provided by NIH AIDS Clinical Trials Information Service:
Ranitidine

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted 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