Status:
COMPLETED
Study Comparing Lopinavir/Ritonavir (LPV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) With a Nucleoside Sparing Regimen Consisting of Lopinavir/Ritonavir + Raltegravir (RAL)
Lead Sponsor:
Abbott
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Human Immunodeficiency Virus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the safety, tolerability, and antiviral activity of the lopinavir/ritonavir tablet when administered in combination with reverse transcriptase inhibitors to lop...
Eligibility Criteria
Inclusion
- Participants must provide written, voluntary informed consent to participate in the study.
- Participants 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.
- Participant's vital signs, physical examination, and laboratory results must not exhibit evidence of acute illness.
- Participant has not been treated for an active acquired immune deficiency syndrome (AIDS)-defining opportunistic infection within 45 days of initiating study drug. Participants who are on stable maintenance therapy for an opportunistic infection may be enrolled after consultation with the Sponsor.
- Participant 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. Participant 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 participants must be either postmenopausal for at least one year, surgically sterile, or must use a non-hormonal method of birth control that is acceptable to both the participant and investigator. All female participants must have a urine pregnancy test performed at screening visit and on Day minus 1/baseline, and results of both tests must be negative. Female participants may not be breastfeeding.
- Participants have received no prior treatment with an HIV-1 integrase inhibitor.
Exclusion
- Participants must not have history of an allergic reaction or significant sensitivity to the study drugs.
- Participants may not have an ongoing history of substance abuse or psychiatric illness that could preclude protocol adherence.
- Participant cannot have resistance to lopinavir/ritonavir, tenofovir, or emtricitabine based on the HIV-1 drug resistance genotypic test results at the screening visit.
- Participant may not have significant medical history of concomitant illness or disease that would adversely affect his/her participating in the study.
- Participants may not have received any investigational drug or investigational vaccine within 30 days prior to study drug administration.
- Participants may not have any of the following abnormal screening results: Hemoglobin \<= 8.0 grams/deciliter, absolute neutrophil count \<= 750 cells/microliter, Platelet count \<= 50,000 per milliliter, alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \[SGPT\]) or aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) \>= 3.0 x upper limit of normal (ULN), calculated creatinine clearance \< 50 milliliter/minute, hepatitis B surface antigen (HBsAg) is positive.
- The investigator considers the participant to be an unsuitable candidate for the study.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT00711009
Start Date
July 1 2008
End Date
October 1 2010
Last Update
February 14 2012
Active Locations (37)
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1
Site Reference ID/Investigator# 8431
Phoenix, Arizona, United States, 85006
2
Site Reference ID/Investigator# 8432
Beverly Hills, California, United States, 90211
3
Site Reference ID/Investigator# 8394
Atlantis, Florida, United States, 33462
4
Site Reference ID/Investigator# 8393
Ft. Pierce, Florida, United States, 34982