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

• Status: Completed
• Trial end date: 1997-06-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine the clinical efficacy of indinavir sulfate or placebo in combination with zidovudine ( AZT ) and lamivudine ( 3TC ) in AIDS patients.

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Indinavir; Lamivudine; Stavudine; Zidovudine

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.