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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

NCT ID: NCT00002106

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Patients are randomized to receive either ranitidine or matching placebo bid for 16 weeks, with follow-up every 4 weeks through week 20.

Conditions

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HIV Infections

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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Ranitidine hydrochloride

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glaxo Wellcome

INDUSTRY

Sponsor Role lead

Locations

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Pacific Oaks Med Group

Sherman Oaks, California, United States

Site Status

Community Research Initiative

Coral Gables, Florida, United States

Site Status

Duke Univ Med Ctr

Durham, North Carolina, United States

Site Status

Houston Clinical Research Network

Houston, Texas, United States

Site Status

Countries

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United States

References

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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

Reference Type BACKGROUND

Other Identifiers

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RAN-809

Identifier Type: -

Identifier Source: secondary_id

135A

Identifier Type: -

Identifier Source: org_study_id