Immunologic and Virologic Consequences of Long-Term Highly Active Antiretroviral Therapy (HAART) in Subjects With Moderately Advanced HIV-1 Disease: A Follow-Up Study to ACTG 315
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Hypersensitivity, Delayed, Follow-Up Studies, Anti-HIV Agents, Viral Load
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Protocol Chair-approved antiretroviral medications or research study treatment for an HIV complication. Treatment, maintenance, or chemoprophylaxis with approved medications for opportunistic infections. Antibiotics. Recombinant erythropoietin (rEPO) and granulocyte colony-stimulating factor (G-CSF, filgrastim). Regularly prescribed medications, such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, oral contraceptives (not as a sole form of birth control), megestrol acetate, testosterone, or any other medication not explicitly excluded. Alternative therapies such as vitamins, acupuncture, and visualization techniques. Patients must have: HIV-positive status. Completion of 48 weeks of study treatment in ACTG 315 and maintenance in this regimen (on-study) until enrollment in this study. Signed, informed consent from parent or legal guardian for patients less than 18 years of age. Exclusion Criteria Co-existing Condition: Patients with the following conditions and symptoms are excluded: Documented or suspected pancreatitis or hepatitis within 2 weeks prior to study entry. Concurrent Medication: Excluded: Immunomodulators that affect immunologic or virologic indices (e.g., systemic corticosteroids, thalidomide, cytokines). Ketoconazole, rifampin, and rifabutin. Amiodarone, astemizole, bepridil, bupropion, cisapride, clozapine, dihydroergotamine, encainide, ergotamine, flecainide, meperidine, pimozide, piroxicam, propafenone, propoxyphene, quinidine, terfenadine, alprazolam, clorazepate, diazepam, estazolam, flurazepam, midazolam, triazolam, zolpidem, phenytoin, phenobarbital, and carbamazepine. [AS PER AMENDMENT 3/5/01: Lovastatin and simvastatin. Excluded for patients who are pregnant: ddI or d4T.] Avoided: Herbal medications. [2. AS PER AMENDMENT 4/10/00: Use of ddI is contraindicated in patients who have serum amylase or lipase values over 1.5 times the ULN (Upper Limit of Normal), fasting triglycerides of 100 mg/dl or more, or a history of pancreatitis. Use ddI with extreme caution and only if clinically indicated in patients with known risk factors. Refer to package insert for more information.] Concurrent Treatment: Excluded: Systemic cytotoxic chemotherapy. Prior Medication: Excluded: Any antiretroviral medications other than the zidovudine, lamivudine, and ritonavir supplied in ACTG 315 or alternative antiretrovirals not approved by protocol chairs, 48 weeks prior to study entry. Immunomodulatory therapies within 30 days prior to study entry. Required: Zidovudine (200 mg tid or 300 mg bid) plus lamivudine (150 mg bid) plus ritonavir (500 or 600 mg bid, or 300 mg tid) for 48 weeks in ACTG 315. Active substance or alcohol abuse or dependence that would interfere with adherence to study requirements.
Sites / Locations
- Univ of Colorado Health Sciences Ctr
- Rush Presbyterian - Saint Luke's Med Ctr
- Case Western Reserve Univ