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

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

Keywords

ClinConnect Summary

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 a...

Gender

ALL

Eligibility 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).

Trial Officials