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

This study has been completed.
Sponsor:
Information provided by:
George Washington University
ClinicalTrials.gov Identifier:
NCT00632970
First received: February 29, 2008
Last updated: July 7, 2011
Last verified: February 2009

February 29, 2008
July 7, 2011
February 2008
February 2010   (final data collection date for primary outcome measure)
Absolute change in CD4 cell counts and HIV RNA. [ Time Frame: 24 and 48 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00632970 on ClinicalTrials.gov Archive Site
Change is plasma lipids, lipoproteins and lipoprotein subtypes. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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. 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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Raltegravir
    1 400mg tablet twice a day
  • Drug: Lopinavir/Ritonavir
    2 tablets twice a day
  • Experimental: Raltegravir
    Intervention: Drug: Raltegravir
  • Active Comparator: Lopinavir/Ritonavir
    Intervention: Drug: Lopinavir/Ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
June 2010
February 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00632970
GS001
Yes
Gary Simon, MD PhD, George Washington University Medical Center
George Washington University
Not Provided
Principal Investigator: Gary Simon, MD, PhD George Washington University
George Washington University
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP