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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Given the extensive immunologic and virologic data available from ACTG 315, follow-up studies of this advanced-disease population are indicated to primarily ascertain the impact of long-term suppression of viral replication on immunologic reconstitution or re-education and the durability of the antiviral effects of HAART.

Patients continue their current ACTG 315 regimen of zidovudine plus lamivudine plus ritonavir in an open-label fashion while undergoing 6 weeks of extensive evaluations. Treatment decisions are based on baseline viral load (mean of 2 viral load measurements taken during 6...

Gender

ALL

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.