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

About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Didanosine, Drug Therapy, Combination, AIDS-Related Complex, Antiviral Agents, Zidovudine, Stavudine, Lamivudine, Drug Combinations
Eligibility 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.
Sites / Locations
- Alabama Therapeutics CRS
- USC CRS
- UCLA CARE Center CRS
- Stanford CRS
- Ucsd, Avrc Crs
- Ucsf Aids Crs
- Santa Clara Valley Med. Ctr.
- San Mateo County AIDS Program
- Harbor-UCLA Med. Ctr. CRS
- University of Colorado Hospital CRS
- Univ. of Miami AIDS CRS
- Emory Univ. Hemophilia Program Office
- Northwestern University CRS
- Cook County Hosp. CORE Ctr.
- Rush Univ. Med. Ctr. ACTG CRS
- Indiana Univ. School of Medicine, Infectious Disease Research Clinic
- Tulane Hemophilia Treatment Ctr.
- Johns Hopkins Adult AIDS CRS
- Massachusetts General Hospital ACTG CRS
- Bmc Actg Crs
- Beth Israel Deaconess - East Campus A0102 CRS
- Beth Israel Deaconess Med. Ctr., ACTG CRS
- University of Minnesota, ACTU
- St. Louis ConnectCare, Infectious Diseases Clinic
- Washington U CRS
- Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
- SUNY - Buffalo, Erie County Medical Ctr.
- NY Univ. HIV/AIDS CRS
- Cornell University A2201
- Univ. of Rochester ACTG CRS
- Unc Aids Crs
- Carolinas HealthCare System, Carolinas Med. Ctr.
- Regional Center for Infectious Disease, Wendover Medical Center CRS
- Univ. of Cincinnati CRS
- Case CRS
- The Ohio State Univ. AIDS CRS
- Hosp. of the Univ. of Pennsylvania CRS
- University of Washington AIDS CRS
- Puerto Rico-AIDS CRS
- Mbeya Med. Research Program, Mbeya Referral Hosp. CRS