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The Effect of Stomach Acid on Foscarnet

This study has been completed.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000964
  Purpose

To see if ranitidine, by reducing stomach acidity, can enhance the effectiveness of foscarnet, by making foscarnet more available to the body.

Foscarnet is an antiviral compound. Laboratory studies have shown it to be active against HIV. However, only 12 - 22 percent of an oral foscarnet dose is absorbed by the body. Ranitidine suppresses gastric acid output, increasing gastric pH. Thus by increasing gastric pH (decreasing stomach acidity), less foscarnet is expected to be decomposed or broken down in the stomach. Thus, more foscarnet should be absorbed into the body.


Condition Intervention Phase
HIV Infections
Drug: Ranitidine hydrochloride
Drug: Foscarnet sodium
Phase I

MedlinePlus related topics:   AIDS   

Drug Information available for:   Ranitidine    Foscarnet    Foscarnet sodium    Fosfonet sodium    Phosphonoacetic acid    Phosphorus    Ranitidine Hydrochloride    Ranitidine bismuth citrate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   The Effect of Increasing Gastric pH Upon the Bioavailability of Orally Administered Phosphonoformic Acid (Foscarnet)

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:   6

Detailed Description:

Foscarnet is an antiviral compound. Laboratory studies have shown it to be active against HIV. However, only 12 - 22 percent of an oral foscarnet dose is absorbed by the body. Ranitidine suppresses gastric acid output, increasing gastric pH. Thus by increasing gastric pH (decreasing stomach acidity), less foscarnet is expected to be decomposed or broken down in the stomach. Thus, more foscarnet should be absorbed into the body.

Six asymptomatic HIV-infected males, or those with limited symptoms of early AIDS-related complex ( ARC ), will receive one dose intravenously of ranitidine in distilled water and one dose of placebo (distilled water alone), followed in 1 hour by foscarnet in oral solution. The order of ranitidine and placebo is randomized and the two foscarnet doses are separated by at least 72 hours. A nasogastric pH probe is placed on each morning of drug administration to monitor gastric pH.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Acetaminophen and sedatives.

Patient must be able to give informed consent.

Exclusion Criteria

Patients with the following are excluded:

  • Unintentional weight loss in excess of 10 pounds or 10 percent of usual body weight within 2 years prior to study.
  • Unexplained temperature above 38 degrees Celsius on more than 5 consecutive days or on more than 10 days in any 30 days in 2 years prior to expected study entry.
  • Unexplained diarrhea defined by two or more stools/day for at least 14 days during a 120-day interval.

Prior Medication:

Excluded within 1 week of entry into study:

  • Probenecid, aspirin, or diuretics.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000964

Locations
United States, Maryland
Johns Hopkins Hosp    
      Baltimore, Maryland, United States, 21205

Sponsors and Collaborators

Investigators
Study Chair:     DM Kornhauser    
  More Information


Publications:
Barditch-Crovo P, Petty BG, Gambertoglio J, Nerhood LJ, Kuwahara S, Hafner R, Lietman PS, Kornhauser DM. The effect of increasing gastric PH upon the bioavailability of orally-administered phosphonoformic acid (foscarnet). Int Conf AIDS. 1991 Jun 16-21;7(2):210 (abstract no WB2115)
 

Study ID Numbers:   ACTG 136
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00000964
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Ranitidine  
Phosphorus Acids  
Drug Evaluation  
Acquired Immunodeficiency Syndrome  

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Phosphonoacetic Acid
Bismuth tripotassium dicitrate
Acquired Immunodeficiency Syndrome
Citric Acid
Immunologic Deficiency Syndromes
Histamine
Bismuth
Virus Diseases
Ranitidine
Ranitidine bismuth citrate
HIV Infections
Sexually Transmitted Diseases
Histamine phosphate
Foscarnet
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
Neurotransmitter Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Histamine Agents
Enzyme Inhibitors
Infection
Antiviral Agents
Histamine H2 Antagonists
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Histamine Antagonists
Anti-Retroviral Agents
Therapeutic Uses
Anti-Ulcer Agents
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 03, 2008




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