Clinical Trials

MainTitle

The Effect of Stomach Acid on Foscarnet

This study has been completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)


Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier
NCT00000964

First received: November 2, 1999
Last updated: March 28, 2012
Last Verified: March 2012
History of Changes
Purpose

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 1

Study Type: Interventional
Study Design: Primary Purpose: 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):

Enrollment: 6
Study Completion Date: October 1990

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

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes 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

Contacts and Locations

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

Locations

United States, Maryland
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States, 21205

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair: DM Kornhauser
More Information

More Information


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)  
ClinicalTrials.gov Identifier: NCT00000964   History of Changes  
Other Study ID Numbers: ACTG 136  
  11111  
Study First Received: November 2, 1999  
Last Updated: March 28, 2012  

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Ranitidine
Phosphorus Acids
Drug Evaluation
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
HIV Infections
Ranitidine
Ranitidine bismuth citrate
Foscarnet
Phosphonoacetic Acid

ClinicalTrials.gov processed this data on November 22, 2017
This information is provided by ClinicalTrials.gov.