Completed

A Study to Evaluate the Short-Term Clinical and Virologic Significance of Zidovudine Resistance

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What is being tested

Zidovudine

+ Didanosine

Drug
Who is being recruted

Blood-Borne Infections+14

+ Urogenital Diseases

+ Genital Diseases

Over 12 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 1, 2021
Sourced from a government-validated database.Claim as a partner

High-grade resistance to AZT has been detected in HIV isolates from approximately 25 percent of individuals with AIDS who received AZT for at least 1 year. To elucidate the clinical significance of in vitro AZT resistance, it is necessary to distinguish between clinical failure caused by AZT resistance and clinical decompensation caused by other factors. One hundred-twenty patients who have been receiving AZT for at least 1 year are randomized to 1) continue with AZT, 2) switch to treatment with didanosine at 1 of 2 doses, or 3) receive both AZT and ddI. Treatment is given for 16 weeks, with a possible extension to 32 weeks. Patients are followed at weeks 2, 4, 8, 12, and 16. For analysis purposes only, patients are stratified according to degree of susceptibility of HIV isolates to AZT.

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 1, 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

120 patients to be enrolled

Total 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.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexHIV Infections

Criteria

Inclusion Criteria Concurrent Medication: Allowed: Chemoprophylaxis against Pneumocystis carinii pneumonia (PCP), Mycobacterium tuberculosis, or Herpes simplex virus, or against other opportunistic infections as indicated. Corticosteroids for no longer than 21 days (only as part of PCP therapy). Erythropoietin and G-CSF. Patients must have: Documented HIV-seropositivity. CD4 count 100 - 300 cells/mm3. Prior continuous AZT dose = or > 300 mg/day for 1 year or longer. Prior Medication: Required: AZT for at least 1 year prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Medical contraindication or is considered noncompliant in the opinion of the investigator. Peripheral neuropathy = or > grade 2. Concurrent Medication: Excluded: Anti-HIV agents other than study drugs. Biologic response modifiers (other than erythropoietin or G-CSF). Systemic cytotoxic chemotherapy. Regularly prescribed medications (such as antipyretics, analgesics, allergy medications) that are associated with an increased risk of pancreatitis, peripheral neuropathy, or bone marrow suppression. Concurrent Treatment: Excluded: Radiation therapy. Patients with the following prior conditions are excluded: History of acute or chronic pancreatitis, gout, or uric acid nephropathy. Prior Medication: Excluded: Other antiretrovirals besides AZT. ddI or ddC for more than 30 days within the past year or any time within 3 months prior to study entry. Acute therapy for an infection or other medical illness within 14 days prior to study entry.

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 18 locations

Univ of Alabama at Birmingham

Birmingham, United StatesOpen Univ of Alabama at Birmingham in Google Maps

San Francisco Gen Hosp

San Francisco, United States

Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium

San Jose, United States

San Mateo AIDS Program / Stanford Univ

Stanford, United States
Completed18 Study Centers