A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months

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

Keywords

ClinConnect Summary

Protease inhibitors such as indinavir sulfate may be effective in patients with advanced HIV disease who have received prior AZT therapy. Since studies suggest that triple drug therapy may have an advantage over both monotherapy and two drug therapy, the combination of indinavir sulfate with AZT and 3TC should be evaluated.

Patients are randomized to receive open-label AZT and 3TC with or without indinavir sulfate for at least 48 weeks. Patients who develop intolerance to AZT or have progressive disease after 24 weeks on study may substitute stavudine ( d4T ) for AZT. Patients are followed...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Required:
• • PCP prophylaxis.
• Allowed:
• • Topical or oral antifungal agents (other than oral ketoconazole).
• • Approved agents for opportunistic infections.
• • Antibiotics unless specifically excluded.
• • Systemic corticosteroids for no more than 21 days.
• • Vitamins.
• • Recombinant erythropoietin.
• • G-CSF.
• • Regularly prescribed medications such as allergy medications, antidepressants, antipyretics, analgesics, oral contraceptives, megestrol, and testosterone.
• Concurrent Treatment:
• Allowed:
• • Acupuncture.
• • Visualization techniques.
• Patients must have:
• • HIV infection.
• • CD4 count \<= 200 cells/mm3.
• • At least 6 months total prior AZT therapy.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Malignancy requiring systemic therapy other than minimal Kaposi's sarcoma.
• Concurrent Medication:
• Excluded:
• • Antiretrovirals other than study drugs.
• • Rifabutin and rifampin.
• • Investigational drugs other than indinavir sulfate.
• • Systemic cytotoxic chemotherapy.
• • Oral ketoconazole.
• • Chronic systemic corticosteroids.
• • Herbal therapies.
• Patients with the following prior conditions are excluded:
• • Unexplained temperature \> 38.5 C for any 7 days within 30 days prior to study entry.
• • Chronic diarrhea persisting for 15 days within 30 days prior to study entry.
• • History of acute or chronic pancreatitis.
• • Acute hepatitis within 30 days prior to study entry.
• • Grade 2 or worse bilateral peripheral neuropathy within 60 days prior to study entry.
• • Dose-limiting intolerance to prior AZT at 600 mg/day.
• Prior Medication:
• Excluded:
• • More than 1 week of prior 3TC.
• • Any prior protease inhibitors.
• • Rifampin or rifabutin within 14 days prior to study entry.
• Excluded within 30 days prior to study entry:
• • Erythropoietin.
• • G-CSF or GM-CSF.
• • Non-nucleoside reverse transcriptase inhibitors.
• • Interferons.
• • Interleukins.
• • HIV vaccines.
• • Any experimental therapy.

Trial Officials