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Home > "T" Clinical Trials Conditions > The Effect of Stomach Acid on Foscarnet  The Effect of Stomach Acid on Foscarnet
The Effect of Stomach Acid on Foscarnet
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Male
Protocol Entry 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.
Total Enrollment: 6
Location and Contact Information:
Overall Study Official:
DMKornhauser, Study Chair,
Johns Hopkins Hosp
Baltimore, Maryland, 21205
United States
Additional Information:
Study ID Numbers: ACTG 136;
Study Start Date:
Record last reviewed: March 1991
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000964
Other Hiv Infections Studies:
1. A Phase I Study of the Safety and Pharmacokinetics of Recombinant Human CD4 Immunoglobulin (rCd4-IgG) Administered by Intravenous Bolus in Patients With AIDS and AIDS Related Complex
2. The Effectiveness of Indinavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients with No Symptoms of Infection
3. Diagnosing Tuberculosis in HIV Infected Children in Peru
4. Ganciclovir: Compassionate Use in Patients With Serious or Life-Threatening Cytomegalovirus Infections
5. Immune Therapies and Anti-HIV Therapy Withdrawal in Controlling Viral Load
Related Studies:
Other HIV Infections Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
The Effect of Stomach Acid on Foscarnet
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