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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00632970
Recruitment Status : Terminated (no patients completed)
First Posted : March 11, 2008
Results First Posted : June 26, 2017
Last Update Posted : June 26, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Raltegravir Drug: Lopinavir/Ritonavir Drug: Truvada Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center Comparison of Raltegravir to Lopinavir/Ritonavir, Both in Combination With Truvada, in HIV-Infected Individuals Naive to Antiretroviral Therapy
Study Start Date : February 2008
Primary Completion Date : February 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

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 Name: Isentress
Drug: Truvada
1 tablet, once a day, with either Raltegravir (Isentress) or Lopinavir/Ritonavir(Kaletra)
Other Name: 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: Lopinavir/Ritonavir
2 tablets twice a day, with Truvada 1 tablet once a day
Other Name: Kaletra
Drug: Truvada
1 tablet, once a day, with either Raltegravir (Isentress) or Lopinavir/Ritonavir(Kaletra)
Other Name: Emtricitabine/Tenofovir disoproxil fumarate

Outcome Measures

Primary Outcome Measures :
  1. Absolute Change in CD4 Cell Counts [ Time Frame: 24 and 48 weeks ]

Secondary Outcome Measures :
  1. Change is Plasma Lipids, Lipoproteins and Lipoprotein Subtypes. [ Time Frame: 24 weeks ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00632970

United States, District of Columbia
George Washington University Medical Faculty Associates
Washington, D.C., District of Columbia, United States, 20037
Sponsors and Collaborators
George Washington University
Principal Investigator: Gary Simon, MD, PhD George Washington University
More Information

Responsible Party: Gary Simon, Professor of Medicine, George Washington University
ClinicalTrials.gov Identifier: NCT00632970     History of Changes
Other Study ID Numbers: GS001
First Posted: March 11, 2008    Key Record Dates
Results First Posted: June 26, 2017
Last Update Posted: June 26, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Findings not relevant

Keywords provided by Gary Simon, George Washington University:

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Raltegravir Potassium
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
HIV Integrase Inhibitors
Integrase Inhibitors