Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy
Lamivudine
+ Stavudine
+ Zidovudine
Blood-Borne Infections+13
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.280 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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
USC CRS
Los Angeles, United StatesUCLA CARE Center CRS
Los Angeles, United StatesStanford CRS
Palo Alto, United States