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 - Full Text View

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.

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

MedlinePlus related topics:

AIDS

ChemIDplus related topics:

Ranitidine Ranitidine Hydrochloride Ranitidine bismuth citrate

U.S. FDA Resources

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

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
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002106
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:

Sexually Transmitted Diseases, Viral

Bismuth tripotassium dicitrate

Acquired Immunodeficiency Syndrome

Citric Acid

Immunologic Deficiency Syndromes

Bismuth

Histamine

Virus Diseases

Ranitidine

Ranitidine bismuth citrate

HIV Infections

Sexually Transmitted Diseases

Histamine phosphate

Retroviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections

Neurotransmitter Agents

Slow Virus Diseases

Molecular Mechanisms of Pharmacological Action

Immune System Diseases

Physiological Effects of Drugs

Gastrointestinal Agents

Histamine Agents

Infection

Pharmacologic Actions

Histamine H2 Antagonists

Histamine Antagonists

Therapeutic Uses

Anti-Ulcer Agents

Lentivirus Infections

ClinicalTrials.gov processed this record on September 05, 2008