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

Abbott

Status and phase: Completed; Phase 3

Conditions: Human Immunodeficiency Virus Infection

Treatments: Drug: emtricitabine/tenofovir disoproxil fumarate (FTC/TDF); Drug: raltegravir (RAL); Drug: lopinavir/ritonavir (LPV/r)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00711009

2008-000881-22 (EudraCT Number)

M10-336

Details and patient eligibility

About

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.

Enrollment: 206 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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206 participants in 2 patient groups

LPV/r + FTC/TDF

Active Comparator group

Description:

lopinavir/ritonavir 400/100 milligram (mg) tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily

Treatment:

Drug: lopinavir/ritonavir (LPV/r)

Drug: emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)

LPV/r + RAL

Experimental group

Description:

lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily

Treatment:

Drug: lopinavir/ritonavir (LPV/r)

Drug: raltegravir (RAL)