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
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Ranitidine hydrochloride (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Glaxo Wellcome
Summary
To evaluate the effect of ranitidine on immunologic indicators in asymptomatic HIV-1 infected
patients with CD4 counts of 400-700 cells/mm3.
Clinical Details
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
Study design: Treatment, Parallel Assignment, Efficacy Study
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Pacific Oaks Med Group, Sherman Oaks, California 91403, United States
Community Research Initiative, Coral Gables, Florida 33146, United States
Duke Univ Med Ctr, Durham, North Carolina 27710, United States
Houston Clinical Research Network, Houston, Texas 77006, United States
Additional Information
Related 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
Last updated: June 23, 2005
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