NCT00000964

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

October 1, 1990

Completed
9.1 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

October 29, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 28, 2021

Conditions

HIV Infections

Keywords

RanitidinePhosphorus AcidsDrug EvaluationAcquired Immunodeficiency Syndrome

Interventions

Ranitidine hydrochlorideDRUG
Foscarnet sodiumDRUG

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Acetaminophen and sedatives.
  • Patient must be able to give informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

  • 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.

    PMID: 9754889BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

RanitidineFoscarnet

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

FuransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhosphonoacetic AcidAcetatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsOrganophosphonatesOrganophosphorus Compounds

Study Officials

  • DM Kornhauser

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

October 1, 1990

Last Updated

October 29, 2021

Record last verified: 2021-10

Locations

US(1)