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
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| ClinicalTrials.gov Identifier: NCT00002106 |
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Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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Sponsor:
Glaxo Wellcome
Information provided by:
NIH AIDS Clinical Trials Information Service
| Tracking Information | |||
|---|---|---|---|
| First Submitted Date ICMJE | November 2, 1999 | ||
| First Posted Date ICMJE | August 31, 2001 | ||
| Last Update Posted Date | June 24, 2005 | ||
| Study Start Date ICMJE | Not Provided | ||
| Primary Completion Date | Not Provided | ||
| Current Primary Outcome Measures ICMJE | Not Provided | ||
| Original Primary Outcome Measures ICMJE | Not Provided | ||
| Change History | No Changes Posted | ||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||
| Current Other Pre-specified Outcome Measures | Not Provided | ||
| Original Other Pre-specified Outcome Measures | Not Provided | ||
| Descriptive Information | |||
| Brief Title ICMJE | 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 | ||
| Official Title ICMJE | 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 | ||
| Brief Summary | 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 | Patients are randomized to receive either ranitidine or matching placebo bid for 16 weeks, with follow-up every 4 weeks through week 20. | ||
| Study Type ICMJE | Interventional | ||
| Study Phase ICMJE | Phase 2 | ||
| Study Design ICMJE | Intervention Model: Parallel Assignment Primary Purpose: Treatment |
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| Condition ICMJE | HIV Infections | ||
| Intervention ICMJE | Drug: Ranitidine hydrochloride | ||
| Study Arms ICMJE | Not Provided | ||
| Publications * | Bartlett JA, Berry PS, Bockman KW, Stein A, Johnson J, Graham S, Quinn J, DeMasi R, Alexander WJ. A placebo-controlled trial of ranitidine in patients with early human immunodeficiency virus infection. J Infect Dis. 1998 Jan;177(1):231-4. doi: 10.1086/517361. | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Completed | ||
| Enrollment ICMJE |
104 | ||
| Original Enrollment ICMJE | Same as current | ||
| Study Completion Date ICMJE | Not Provided | ||
| Primary Completion Date | Not Provided | ||
| Eligibility Criteria ICMJE | Inclusion Criteria Patients must have:
Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded:
Prior Medication: Excluded:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers ICMJE | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT00002106 | ||
| Other Study ID Numbers ICMJE | 135A RAN-809 |
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| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement ICMJE | Not Provided | ||
| Current Responsible Party | Not Provided | ||
| Original Responsible Party | Same as current | ||
| Current Study Sponsor ICMJE | Glaxo Wellcome | ||
| Original Study Sponsor ICMJE | Same as current | ||
| Collaborators ICMJE | Not Provided | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | NIH AIDS Clinical Trials Information Service | ||
| Verification Date | May 1994 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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