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.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsored by:	Glaxo Wellcome
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002106

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 II

Study Type:	Interventional
Study Design:	Treatment, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: AIDS

Drug Information available for: Ranitidine Ranitidine Hydrochloride Ranitidine bismuth citrate

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Study ID Numbers:	135A, RAN-809
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002106 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Ranitidine

Study placed in the following topic categories:

Neurotransmitter Agents
Sexually Transmitted Diseases, Viral
Bismuth tripotassium dicitrate
Acquired Immunodeficiency Syndrome
Citric Acid
Histamine H2 Antagonists
Immunologic Deficiency Syndromes
Bismuth
Histamine

Virus Diseases
Ranitidine
Histamine Antagonists
Ranitidine bismuth citrate
HIV Infections
Sexually Transmitted Diseases
Citrate
Histamine phosphate
Retroviridae Infections

Additional relevant MeSH terms:

Neurotransmitter Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Physiological Effects of Drugs
Acquired Immunodeficiency Syndrome
Gastrointestinal Agents
Histamine Agents
Infection
Histamine H2 Antagonists

Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
Ranitidine
Histamine Antagonists
Ranitidine bismuth citrate
HIV Infections
Therapeutic Uses
Anti-Ulcer Agents
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on July 02, 2009