A Phase 3, Randomized, Open-Label, Study of Lopinavir/Ritonavir Tablets Versus Soft Gel Capsules and Once Daily Versus Twice-Daily Administration, When Co-Administered With NRTIs in Antiretroviral Naive HIV-1 Infected Subjects - Article Orazinc; Verazinc; Zinc 15; Zinc Gluconate; Zinc Sulfate; Zincate
Clinical Trial: A Phase 3, Randomized, Open-Label, Study of Lopinavir/Ritonavir Tablets Versus Soft Gel Capsules and Once Daily Versus Twice-Daily Administration, When Co-Administered With NRTIs in Antiretroviral Naive HIV-1 Infected Subjects
This study is not yet open for patient recruitment.
Verified by Abbott Laboratories December 2005
The primary objectives of this study are:
- To compare the safety and tolerability of the lopinavir/ritonavir tablet formulation with the soft gelatin capsule formulation.
- To compare the safety, tolerability, and antiviral activity of once daily (QD) and twice daily (BID) dosing of the lopinavir/ritonavir tablet formulation.
|HIV Infection || Drug: Lopinavir/ritonavir (tablet or capsule) with NRTIs ||Phase III |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label
- Subjects must provide written, voluntary informed consent to participate in the study.
- Subjects must be naive to antiretroviral treatment with HIV RNA greater than or equal to 1,000 copies/mL at screening, and in the investigator''''s opinion, require antiretroviral therapy.
- Subjects'''' vital signs, physical examination and laboratory results do not exhibit evidence of acute illness. Subject has not been treated for an active AIDS-defining opportunistic infection within 45 days of initiating study drug. Subjects who are on stable maintenance therapy for an opportunistic infection may be enrolled after consultation with Sponsor.
- Subject does not require and agrees not to take any drugs that are contraindicated or have significant pharmacokinetic interactions with study drugs during the course of the study. Subject agrees not to take any medication during the study, including over the counter medicines, vitamins, minerals, herbal preparations, alcohol or recreational drugs without the knowledge and permission of the principal investigator.
- Female subjects must not be of childbearing potential or must be practicing one of the following methods of birth control: condoms, sponge, foams, jellies, diaphragm or intrauterine device, a vasectonmized partner, or total abstinence from sexual intercourse. For female subjects of childbearing potential, urine pregnancy tests at screening and Day-1/baseline must be negative. Female subjects may not be breastfeeding.
- Subjects must not have history of an allergic reaction or significant sensitivity to study drugs.
- Subjects may not have an ongoing history of substance abuse or psychiatric illness that could preclude protocol adherence.
- Subjects may not have significant history of cardiac, renal, neurologic, psychiatric, oncologic, metabolic or hepatic disease that would adversely affect his/her participating in this study.
- Subjects may not have received any investigational drug or vaccine within 30 days prior to study drug administration.
- Subjects may not have any of the following abnormal laboratory results at screening: Presence of hepatitis B surface antigen (HBsAg), Hemoglobin<=8.0g/dL, Absolute neutrophil count <=750 cells/mL, Platelet count<=50,000 per mL, ALT (SGOT) or AST (SGPT)>=3.0x Upper Limit of Normal (ULN), Calculated creatinine clearance<50 mL/min
Location and Contact Information
Last Updated: December 16, 2005
Record first received: December 5, 2005
ClinicalTrials.gov Identifier: NCT00262522
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10