Overview

The Effect of Stomach Acid on Foscarnet

Status:
Completed
Trial end date:
1990-10-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
Foscarnet
Phosphonoacetic Acid
Ranitidine
Ranitidine bismuth citrate
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.