Raltegravir vs. Lopinavir/Ritonavir, Both in Combination With Truvada, in HIV+ Treatment Naive Individuals

Study Overview
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Brief Summary
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This program is designed to study the efficacy, safety, lipid effects and tolerability of raltegravir compared to lopinavir/ritonavir, in patients with HIV-I infection who have not received prior antiretroviral therapy. All patients will receive concomitant therapy with Truvada.

Detailed Description
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It is hypothesized that (1) the raltegravir regimen will have similar efficacy in terms of both viral suppression as well as increases in CD4 cell counts and (2) raltegravir will have significantly less impact on plasma lipids, lipoproteins and lipoproteins subtypes, compared with lopinavir/ritonavir.

Official Title
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A Multi-Center Comparison of Raltegravir to Lopinavir/Ritonavir, Both in Combination With Truvada, in HIV-Infected Individuals Naive to Antiretroviral Therapy

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Raltegravir
* Drug: Lopinavir/Ritonavir
* Drug: Truvada


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented HIV infection confirmed by western blot or HIV RNA. At least 18 years of age. Less than 1 week of prior antiretroviral therapy. In the opinion of the investigator, patients should be clinically stable. Patients may be on chronic suppressive therapy for opportunistic infections such as MAC or CMV. Patients who are of reproductive potential agree to use an acceptable method of birth control throughout the study. Acceptable methods include an intrauterine device (IUD), diaphragm with spermicide, condoms, or abstinence. HIV RNA > 5000 copies/ml. No restriction on CD4 cell count. A negative urine pregnancy test on the day of initiation of therapy. Exclusion Criteria: Prior treatment with >1week of antiretroviral therapy. Patient requires or is anticipated to require any of the prohibited medications noted in the protocol. HIV RNA < 5000 prior to receiving therapy. Baseline resistance to any of the study regimen drugs on genotype testing. Patients with acute hepatitis due to any cause or clinically significant chronic liver disease. Patient with severe renal insufficiency defined as a calculated creatinine clearance at time of screening <30mL/min, based on the Cockcroft-Gault equation which is as follows (and 0.85X this value for females): Clcr(mL/min) = (l40-age) x weight (in kg)72 x serum creatinine (mg/dL). Patient has a condition (including but not limited to alcohol or other substance abuse) which in the opinion of the investigator would interfere with patient compliance or safety. A female patient who is pregnant, breast-feeding, or expecting to conceive or donate eggs during the study; or a male patient who is planning to impregnate or provide sperm donation during the study is excluded. Inability to obtain signed informed consent from a patient age 18 or older. Patient has significant hypersensitivity or other contraindication to any of the components of the study drug. Patients who should be treated for hyperlipidemia as per NCEPIII guidelines and patients who are currently receiving lipid-lowering therapy are excluded.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Raltegravir plus Truvada<br>Raltegravir (400mg), 1 tablet, administered twice daily (BID) and Truvada (Emtricitabine/Tenofovir disoproxil fumarate) (200mg/300mg), 1 tablet administered once daily (QD) | Drug: Raltegravir<br>* 1, 400mg tablet twice a day, with Truvada 1 tablet once a day<br>* Other names: Isentress;Drug: Truvada<br>* 1 tablet, once a day, with either Raltegravir (Isentress) or Lopinavir/Ritonavir(Kaletra)<br>* Other names: Emtricitabine/Tenofovir disoproxil fumarate;|
| Active Comparator: Lopinavir/Ritonavir plus Truvada<br>Lopinavir/Ritonavir (400mg/100mg) (Kaletra), 2 tablets administered twice daily (BID) and Truvada (Emtricitabine/Tenofovir disoproxil fumarate) (200mg/300mg), 1 tablet administered once daily (QD) | Drug: Lopinavir/Ritonavir<br>* 2 tablets twice a day, with Truvada 1 tablet once a day<br>* Other names: Kaletra;Drug: Truvada<br>* 1 tablet, once a day, with either Raltegravir (Isentress) or Lopinavir/Ritonavir(Kaletra)<br>* Other names: Emtricitabine/Tenofovir disoproxil fumarate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Change in CD4 Cell Counts |  | 24 and 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change is Plasma Lipids, Lipoproteins and Lipoprotein Subtypes. |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Raltegravir, Lopinavir