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:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002106
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: May 1994

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002106 on ClinicalTrials.gov Archive Site
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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
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

To evaluate the effect of ranitidine on immunologic indicators in asymptomatic HIV-1 infected patients with CD4 counts of 400-700 cells/mm3.

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

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
HIV Infections
Drug: Ranitidine hydrochloride
Not Provided
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002106
135A, RAN-809
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Glaxo Wellcome
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NIH AIDS Clinical Trials Information Service
May 1994

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP