Completed

A Phase I/II, Open Label Study to Evaluate the Antiviral Potential of Combination Zidovudine and 2' 3'-Dideoxyinosine (Didanosine) in Patients With Asymptomatic HIV Disease

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What is being tested

Zidovudine

+ Didanosine
Drug
Who is being recruted

HIV Infections

Over 12 Years
How is the trial designed

Treatment Study

Phase 1
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 3, 2021
Sourced from a government-validated database.Claim as a partner

To assess the safety and to evaluate the anti-HIV effect of low-, moderate-, and high-dose schedules of zidovudine (AZT) plus didanosine (ddI) versus ddI alone in asymptomatic HIV-infected patients. Because of the failure with long-term (more than 1 year) use of, frequency of toxicity from, and drug resistance to AZT, drug combinations need to be developed to enable lower, less toxic doses of AZT to be used and to slow or prevent the development of resistance, while providing at least the same effectiveness. Because of the failure with long-term (more than 1 year) use of, frequency of toxicity from, and drug resistance to AZT, drug combinations need to be developed to enable lower, less toxic doses of AZT to be used and to slow or prevent the development of resistance, while providing at least the same effectiveness. Enrollment during the first 8 weeks of the study is restricted to hemophiliacs and sexual partners of hemophiliacs with asymptomatic HIV disease. After the initial 8 weeks this restriction is lifted. Patients are randomized to one of four treatment arms with dosing of AZT plus ddI or ddI alone.

Official TitleA Phase I/II, Open Label Study to Evaluate the Antiviral Potential of Combination Zidovudine and 2' 3'-Dideoxyinosine (Didanosine) in Patients With Asymptomatic HIV Disease 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 3, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
116 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 12 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
Criteria

Inclusion Criteria Concurrent Medication: Allowed: * Aerosolized pentamidine. * Acute and intermittent therapy with mycostatin and mycelex. * Isoniazid, if no alternative therapy is available. Allowed for up to 2 weeks: * Acyclovir for Herpes infection (withhold didanosine during therapy). * Acute therapy with fluconazole or ketoconazole. Allowed but preferably not on a continuous basis for \> 72 hours: * Acetaminophen. * Ibuprofen. * Nonsteroidal antiinflammatory agents. Patients must be: * HIV antibody positive. * Asymptomatic or have persistent generalized lymphadenopathy. * Diagnosed with one of the listed coagulopathies. * OR Sexual partner of someone with the above criteria. Allowed: * Basal cell carcinoma or in situ carcinoma of the cervix. NOTE: * As of January, 1991 full accrual of patients with prior AZT use has been reached - NOW ACCRUING ONLY THOSE WITH NO PRIOR AZT USE. Hemophilia restriction has been lifted. Prior Medication: Allowed: * Zidovudine (AZT) for a total of = or \< 13 months. NOTE: * As of January, 1991 accrual of these patients was reached, NOW ONLY PATIENTS WITH NO PRIOR AZT. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: * Unexplained temperature \> 38 degrees C for more than 5 consecutive days or on more than 10 days in any 30-day period in the 2 years prior to study entry. * Unexplained diarrhea defined as at least 3 liquid stools/day persisting more than 7 days within 2 years prior to study entry. * Unintentional weight loss of \> 10 pounds or \> 10 percent of usual body weight within 2 years prior to study entry. * Oral hairy leukoplakia at any time prior to study entry. * Recurrent oral candidiasis unrelated to the use of antibiotics within 2 years prior to entry or unrelated to the use of antibiotics within the past 3 months. * Herpes zoster within 2 years prior to study entry. * Seizures within the past 6 months or currently requiring anticonvulsants for control. * Current heart disease. * Current psychological or emotional problems sufficient in the investigator's opinion to prevent adequate compliance with study therapy. * Gout. Concurrent Medication: Excluded: * Rifampin. * Chemoprophylaxis for Pneumocystis carinii pneumonia other than aerosolized pentamidine. * Intravenous pentamidine. * Other antiretroviral agents, experimental medication, biological response modifiers, systemic corticosteroids, cimetidine, and ranitidine. * Barbiturates. * Oral acidifying agents. Patients with a history of any of the following are excluded: * AIDS-defining opportunistic infection, advanced AIDS-related complex, or malignancy. * Acute or chronic pancreatitis. * Grade 2 or higher neuropathy based on the Neuropathy Targeted Symptom Questionnaire. * Seizures. * Zidovudine therapy for = or \> 13 months. * Heart disease. * Psychological or emotional problems sufficient in the investigator's opinion to prevent adequate compliance with study therapy. * Gout. Prior Medication: Excluded within 4 weeks of study entry: * Antiretroviral agents, including ribavirin, HPA-23, rifampin, AL721. * Excluded within 3 months of study entry: * Significant course of immunomodulating agents, such as steroids (\> 1 week), isoprinosine, thymic factors, or any other experimental drugs. * Excluded within 30 days prior to study entry: * Neurotoxic drugs. Excluded: * Didanosine (ddI). * Dideoxycytidine (ddC). * Zidovudine (AZT) if received for \> 13 months. Prior Treatment: Excluded within 3 months of entry: * Other experimental therapy. History of recent alcohol abuse.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 5 locations
Suspended
Palo Alto Veterans Adm Med Ctr / Stanford UnivPalo Alto, United StatesSee the location
Suspended
Whitman - Walker ClinicWashington, United States
Suspended
Univ of PittsburghPittsburgh, United States
Suspended
Univ of Pittsburgh Med SchoolPittsburgh, United States

Completed5 Study Centers