The Effect of Stomach Acid on Foscarnet

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Completion Date

1990-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections

Keywords

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Ranitidine Phosphorus Acids Drug Evaluation Acquired Immunodeficiency Syndrome

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Ranitidine hydrochloride

Intervention Type DRUG

Foscarnet sodium

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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DM Kornhauser

Role: STUDY_CHAIR

Locations

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Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Barditch-Crovo PA, 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 foscarnet. Antiviral Res. 1998 Jun;38(3):209-12. doi: 10.1016/s0166-3542(98)00024-2.

Reference Type BACKGROUND

PMID: 9754889 (View on PubMed)

Other Identifiers

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11111

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACTG 136

Identifier Type: -

Identifier Source: org_study_id