A Study of Three Treatment Combinations Using Zidovudine Plus Lamivudine Plus Indinavir in HIV-Infected Patients

• Status: Completed
• Trial end date: 1997-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare the proportion of patients who sustain suppression of plasma HIV RNA to undetectable levels [AS PER AMENDMENT 09/19/97: below 200 copies/mL by Roche UltraSensitive assay] among the 3 regimens during the maintenance phase.

The objective of antiretroviral therapy is to reduce HIV replication, preserve immunologic function and delay the development of HIV-related complications. In patients administered potent antiretroviral regimens, HIV RNA levels are reduced below 500 copies/ml of plasma and below the level of detection of commercially available assays. This protocol attempts to learn if a less intensive regimen can successfully sustain viral suppression after induction with a triple-drug regimen. The study also addresses whether HIV can be eradicated in patients following prolonged treatment with induction and maintenance regimens.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria

Patients must have:

• Documented HIV infection.

• A CD4 cell count >= 200 cells/mm3 within 90 days prior to study entry.

• Plasma HIV RNA >= 1000 copies/ml within 90 days prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following conditions or symptoms are excluded:

• A malignancy that requires systemic chemotherapy.

Concurrent Medication:

Excluded:

• Oral ketoconazole (Nizoral), terfenadine (Seldane), astemizole (Hismanal), cisapride (Propulsid), triazolam (Halcion) or midazolam (Versed).

• All antiretroviral therapies other than study medications.

• Rifabutin and rifampin.

• Investigational drugs and vaccines.

• Systemic cytotoxic chemotherapy.

• Interferon, interleukins, GM-CSF and HIV vaccines.

Patients with any of the following prior conditions are excluded:

• Unexplained temperature > 38.5 degrees C for any 7 days within 30 days prior to study entry.

• Chronic diarrhea as defined as > 3 liquid stools per day persisting for 15 days within 30 days prior to study entry.

• Proven or suspected acute hepatitis within 30 days prior to study entry, even if AST and ALT are <= 5.0 X ULN (upper limit of normal).

• A history of >= Grade 2 bilateral peripheral neuropathy within 60 days prior to study entry.

• A history of intolerance to 300 mg/day of ZDV defined as any toxicity requiring a dose reduction or termination of ZDV.

Prior Medication:

Excluded:

• Acute therapy for an infection or other medical illness within 14 days prior to study entry.

• Any prior therapy with 3TC or experimental drug 1592.

• More than 2 weeks of lifetime exposure to protease inhibitor therapy; any exposure within 14 days prior to study entry.

• Interferons, interleukins, GM-CSF or HIV vaccines within 30 days prior to study entry.

• Any experimental therapy (drugs or vaccines) within 30 days prior to study entry.

• Rifampin or rifabutin within 14 days prior to study entry.

• Systemic cytotoxic chemotherapy within 30 days prior to study entry.

• Oral ketoconazole (Nizoral), terfenadine (Seldane), astemizole (Hismanal), cisapride (Propulsid), triazolam (Halcion) or midazolam (Versed).