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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Human Immunodeficiency Virus Infection

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants Responding (Plasma HIV-1 Ribonucleic Acid [RNA] Levels Less Than 40 Copies/Milliliter [mL]) at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm

Outcome Description:

A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died.

Outcome Time Frame:

Baseline to Week 48

Safety Issue:

No

Principal Investigator

Thomas J Podsadecki, MD

Investigator Role:

Study Director

Investigator Affiliation:

Abbott

Authority:

United States: Food and Drug Administration

Study ID:

M10-336

NCT ID:

NCT00711009

Start Date:

July 2008

Completion Date:

October 2010

Related Keywords:

  • Human Immunodeficiency Virus Infection
  • Human Immunodeficiency Virus infection
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Immunologic Deficiency Syndromes
  • Virus Diseases

Name

Location

Site Reference ID/Investigator# 8431Phoenix, Arizona  85006
Site Reference ID/Investigator# 8432Beverly Hills, California  90211
Site Reference ID/Investigator# 8394Atlantis, Florida  33462
Site Reference ID/Investigator# 8393Fort Pierce, Florida  34982
Site Reference ID/Investigator# 8425Orlando, Florida  32803
Site Reference ID/Investigator# 8402Tampa, Florida  33614
Site Reference ID/Investigator# 8396Vero Beach, Florida  32960
Site Reference ID/Investigator# 8395Atlanta, Georgia  30303
Site Reference ID/Investigator# 8429Decatur, Georgia  30033
Site Reference ID/Investigator# 8424Boston, Massachusetts  02215
Site Reference ID/Investigator# 8426Charlotte, North Carolina  28209
Site Reference ID/Investigator# 11461Huntersville, North Carolina  28078
Site Reference ID/Investigator# 8403Dallas, Texas  75246
Site Reference ID/Investigator# 8433Houston, Texas  77004