Completed

Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy

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What is being tested

Lamivudine

+ Stavudine

+ Zidovudine

Drug
Who is being recruted

Blood-Borne Infections+13

+ 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 4, 2021
Sourced from a government-validated database.Claim as a partner

Characteristics of virus replication, pathogenicity, and resistance are thought to determine the durability of virologic and clinical response to nucleoside reverse transcriptase inhibitors. Previous results of ACTG 175 suggest that either a switch to ddI or addition of ddI in patients receiving AZT results in better clinical, virologic, and CD4 cell response compared to continuation of AZT alone. Patients with prior AZT experience only are randomized to receive either d4T alone or AZT/3TC. Patients with prior ddI experience only are randomized to receive ddI/AZT or ddI/AZT/3TC. PER AMENDMENT 8/27/96: The study has been extended 6 months and treatment will be available until March 15, 1997 at the latest. Each patient will have regularly scheduled 12 week safety visits during the extension period. AS PER AMENDMENT 1/22/97: The study has been extended for approximately 16 additional weeks beyond the current 6-month extension. Subjects will be unblinded to their assigned regimen beginning 2/21/97 and will continue therapy for up to 16 weeks in open-label fashion. AS PER AMENDMENT 5/9/97: The study has been extended for an additional 8 weeks; study drug will not be provided after 9/15/97.

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 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

280 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 InfectionsAIDS-Related ComplexHIV Infections

Criteria

Inclusion Criteria Concurrent Medication: Recommended: PCP prophylaxis in patients with CD4 count <= 200 cells/mm3. Allowed: Chemophylaxis against Mycobacterium tuberculosis. Acyclovir. Vaccination with pneumococcal vaccine polyvalent. Haemophilus B Conjugate vaccine. Chemoprophylaxis for MAC and Toxoplasma gondii. Antibiotics. Recombinant erythropoietin ( EPO ) and G-CSF. Systemic corticosteroids for < 21 days. Regularly prescribed medications such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, and oral contraceptives. Vitamins and herbal therapies. Concurrent Treatment: Allowed: Limited local radiation therapy to skin. Blood transfusions if 3 units or less per 21-day period. Acupuncture. Visualization techniques. Patients must have: Completed AZT or ddI monotherapy on ACTG 175 and remained on that regimen during any subsequent interval. Not reached an ACTG 175 endpoint prior to May 1, 1995. Consent of parent or guardian if less than 18 years old. PER AMENDMENT 8/27/96: Patients must be on study/on treatment at the time the protocol study treatment is extended. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Grade 2 or worse peripheral neuropathy. Malignancy requiring systemic therapy. Concurrent Medication: Excluded: Anti-HIV drugs other than study drugs. Biologic response modifiers. Systemic cytotoxic chemotherapy. Any drug known to affect glucuronidation and/or clearance of AZT. Concurrent Treatment: Excluded: Radiation therapy other than limited local therapy to skin. Patients with the following prior condition are excluded: History of acute or chronic pancreatitis. Prior Medication: Excluded: Prior 3TC. Acute therapy for an infection (other than HIV) or other medical illness within 14 days prior to study entry. Current ethanol 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 40 locations

Alabama Therapeutics CRS

Birmingham, United StatesOpen Alabama Therapeutics CRS in Google Maps

USC CRS

Los Angeles, United States

UCLA CARE Center CRS

Los Angeles, United States

Stanford CRS

Palo Alto, United States
Completed40 Study Centers