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

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

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.

Study Overview

• Status: Terminated
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Raltegravir; Drug: Truvada; Drug: Lopinavir/Ritonavir

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University Medical Faculty Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Documented HIV infection confirmed by western blot or HIV RNA.
2. At least 18 years of age.
3. Less than 1 week of prior antiretroviral therapy.
4. 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.
5. 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.
6. HIV RNA > 5000 copies/ml. No restriction on CD4 cell count.
7. A negative urine pregnancy test on the day of initiation of therapy.

Exclusion Criteria:

1. Prior treatment with >1week of antiretroviral therapy.
2. Patient requires or is anticipated to require any of the prohibited medications noted in the protocol.
3. HIV RNA < 5000 prior to receiving therapy.
4. Baseline resistance to any of the study regimen drugs on genotype testing.
5. Patients with acute hepatitis due to any cause or clinically significant chronic liver disease.
6. 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).
7. 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.
8. 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.
9. Inability to obtain signed informed consent from a patient age 18 or older.
10. Patient has significant hypersensitivity or other contraindication to any of the components of the study drug.
11. Patients who should be treated for hyperlipidemia as per NCEPIII guidelines and patients who are currently receiving lipid-lowering therapy are excluded.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: George Washington University
• Investigators: Principal Investigator: Gary Simon, MD, PhD, George Washington University

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: February 29, 2008
• First Submitted That Met QC Criteria: March 10, 2008
• First Posted (Estimate): March 11, 2008

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 3, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Raltegravir; Lopinavir
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Integrase Inhibitors; Integrase Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Tenofovir; Emtricitabine; Raltegravir Potassium; Ritonavir; Lopinavir; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
• Other Study ID Numbers: GS001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Findings not relevant