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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

To elucidate the relationship between virologic risk factors and immunologic and clinical progression in patients receiving monotherapy in protocol ACTG 175, and to compare new treatment regimens with combinations of reverse transcriptase inhibitors in long-term recipients of monotherapy. Specifically, to determine, in patients who have been taking zidovudine (AZT) alone for a long time, whether it is beneficial to add lamivudine (3TC) to AZT or to switch to d4T alone, and also to determine, in patients who have been taking didanosine (ddI) alone for a long time, whether it is beneficial to add AZT or AZT/3TC to ddI. 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.

Key facts

Study ID

NCT00000831

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

280

Expected to finish

1998-05-01

Last updated by the study team

2021-11-04

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:

You may not qualify if…

• 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.

Where it is running

• Alabama Therapeutics CRS — Birmingham, Alabama, United States
• USC CRS — Los Angeles, California, United States
• UCLA CARE Center CRS — Los Angeles, California, United States
• Stanford CRS — Palo Alto, California, United States
• Ucsd, Avrc Crs — San Diego, California, United States
• Ucsf Aids Crs — San Francisco, California, United States
• Santa Clara Valley Med. Ctr. — San Jose, California, United States
• San Mateo County AIDS Program — San Mateo, California, United States
• Harbor-UCLA Med. Ctr. CRS — Torrance, California, United States
• University of Colorado Hospital CRS — Aurora, Colorado, United States
• Univ. of Miami AIDS CRS — Miami, Florida, United States
• Emory Univ. Hemophilia Program Office — Atlanta, Georgia, United States
• Northwestern University CRS — Chicago, Illinois, United States
• Cook County Hosp. CORE Ctr. — Chicago, Illinois, United States
• Rush Univ. Med. Ctr. ACTG CRS — Chicago, Illinois, United States
• Indiana Univ. School of Medicine, Infectious Disease Research Clinic — Indianapolis, Indiana, United States
• Tulane Hemophilia Treatment Ctr. — New Orleans, Louisiana, United States
• Johns Hopkins Adult AIDS CRS — Baltimore, Maryland, United States
• Massachusetts General Hospital ACTG CRS — Boston, Massachusetts, United States
• Bmc Actg Crs — Boston, Massachusetts, United States
• Beth Israel Deaconess - East Campus A0102 CRS — Boston, Massachusetts, United States
• Beth Israel Deaconess Med. Ctr., ACTG CRS — Boston, Massachusetts, United States
• University of Minnesota, ACTU — Minneapolis, Minnesota, United States
• St. Louis ConnectCare, Infectious Diseases Clinic — St Louis, Missouri, United States
• Washington U CRS — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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