A Study to Evaluate the Effect of Cimetidine on CD4 Lymphocyte Counts in HIV Infection
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00002092 |
|
Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Drug: Cimetidine | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Primary Purpose: | Treatment |
| Official Title: | A Study to Evaluate the Effect of Cimetidine on CD4 Lymphocyte Counts in HIV Infection |
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Concurrent Medication:
Allowed:
- All FDA-approved medications, antiretrovirals, and PCP prophylaxis drugs, with the exception of warfarin (Coumadin).
- Other self-prescribed medications available either over the counter or through buyer's clubs.
Patients must have:
HIV positivity.
NOTE:
- Patients on an antiviral or immunomodulating drug must have received it for at least 2 months and have no intention to make clinical or therapeutic changes in the first 8 weeks (such as adding a new agent or discontinuing effective viral suppressive therapy) that may interfere with the study.
NOTE:
- Patients who become pregnant after enrollment will be permitted to continue on study drug but must sign an additional informed consent indicating their awareness of the issues in taking a drug with limited safety data during pregnancy.
Prior Medication:
Allowed:
- Antiviral and immunomodulating drugs, provided patient has been on such therapy for at least 2 months prior to study entry.
Exclusion Criteria:
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Known intolerance or hypersensitivity to cimetidine.
- Evidence of active opportunistic infection or malignancy requiring high-dose systemic chemotherapy.
- Any symptoms suggestive of concurrent illness that are not attributable to overall impairment by HIV or are not diagnosable based on the available evidence.
- Inability to swallow tablets (gastric feeding tubes are allowed).
- Not willing to comply with visit schedule and study procedures.
Concurrent Medication:
Excluded:
- Warfarin (Coumadin).
Prior Medication:
Excluded within 4 weeks prior to study entry:
- cimetidine (Tagamet), ranitidine (Zantac), famotidine (Pepcid), and nizatidine (Axid).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002092
| United States, Massachusetts | |
| CRI of New England | |
| Brookline, Massachusetts, United States, 02445 | |
| ClinicalTrials.gov Identifier: | NCT00002092 |
| Other Study ID Numbers: |
119A 92-01 |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | June 24, 2005 |
| Last Verified: | March 1996 |
|
Acquired Immunodeficiency Syndrome AIDS-Related Complex Cimetidine |
|
Infections Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome Disease Attributes Pathologic Processes Blood-Borne Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Slow Virus Diseases Cimetidine Anti-Ulcer Agents Gastrointestinal Agents Histamine H2 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cytochrome P-450 CYP1A2 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors |

