The Effect of Stomach Acid on Foscarnet
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Ranitidine hydrochloride (Drug); Foscarnet sodium (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
DM Kornhauser, Study Chair
Summary
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.
Clinical Details
Official title: The Effect of Increasing Gastric pH Upon the Bioavailability of Orally Administered Phosphonoformic Acid (Foscarnet)
Study design: Primary Purpose: Treatment
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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.
Locations and Contacts
Johns Hopkins Adult AIDS CRS, Baltimore, Maryland 21205, United States
Additional Information
Related 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)
Last updated: March 28, 2012
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