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Study Comparing Lopinavir/Ritonavir (LPV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) With a Nucleoside Sparing Regimen Consisting of Lopinavir/Ritonavir + Raltegravir (RAL) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study Comparing Lopinavir/Ritonavir (LPV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) With a Nucleoside Sparing Regimen Consisting of Lopinavir/Ritonavir + Raltegravir (RAL)

A Randomized, Open-label Study of Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Co-formulated Emtricitabine/Tenofovir Disoproxil Fumarate 200/300 mg Once Daily Versus Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Raltegravir 400 mg Twice Daily in Antiretroviral Naive, HIV-1 Infected Subjects

NCT00711009•Abbott

View on ClinicalTrials.gov

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 lopinavir/ritonavir tablets when administered in combination with a human immunodeficiency virus type 1 ( HIV-1) integrase inhibitor in antiretroviral naive HIV-1 infected subjects.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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.

Locations (37)

Site Reference ID/Investigator# 8431

Phoenix, Arizona, United States

Site Reference ID/Investigator# 8432

Beverly Hills, California, United States

Site Reference ID/Investigator# 8394

Atlantis, Florida, United States

Site Reference ID/Investigator# 8393

Ft. Pierce, Florida, United States

Site Reference ID/Investigator# 8425

Orlando, Florida, United States

Site Reference ID/Investigator# 8402

Tampa, Florida, United States

Site Reference ID/Investigator# 8396

Vero Beach, Florida, United States

Site Reference ID/Investigator# 8395

Atlanta, Georgia, United States

Site Reference ID/Investigator# 8429

Decatur, Georgia, United States

Site Reference ID/Investigator# 8424

Boston, Massachusetts, United States

Key Dates

Start Date

July 1, 2008

Primary Completion Date

November 1, 2009

Completion Date

October 1, 2010

Last Updated

February 14, 2012

Enrollment

206

ACTUAL participants

Conditions

Human Immunodeficiency Virus Infection

Interventions

lopinavir/ritonavir (LPV/r)

DRUG

emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)

DRUG

raltegravir (RAL)

DRUG

HPV Infection, Sexually Transmitted Infections and Anal Dysplasia in the Transgender Population

NCT05981807

Human Papillomavirus InfectionHuman Immunodeficiency Virus Infection+1 more

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COMPLETEDPHASE4

Mechanisms of Immune Reconstitution & Reduced Immune Activation Following Darunavir-based ART

NCT01869634

Human Immunodeficiency Virus Infection

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 14, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study Comparing Lopinavir/Ritonavir (LPV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) With a Nucleoside Sparing Regimen Consisting of Lopinavir/Ritonavir + Raltegravir (RAL)

Inclusion Criteria

Exclusion Criteria

HPV Infection, Sexually Transmitted Infections and Anal Dysplasia in the Transgender Population

Mechanisms of Immune Reconstitution & Reduced Immune Activation Following Darunavir-based ART

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