Raltegravir vs. Lopinavir/Ritonavir, Both in Combination With Truvada, in HIV+ Treatment Naive Individuals
This study has been completed.
Sponsor:
George Washington University
Information provided by:
George Washington University
ClinicalTrials.gov Identifier:
NCT00632970
First received: February 29, 2008
Last updated: July 7, 2011
Last verified: February 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Raltegravir Drug: Lopinavir/Ritonavir |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by George Washington University:
Primary Outcome Measures:
- Absolute change in CD4 cell counts and HIV RNA. [ Time Frame: 24 and 48 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change is plasma lipids, lipoproteins and lipoprotein subtypes. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | February 2008 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Raltegravir |
Drug: Raltegravir
1 400mg tablet twice a day
|
| Active Comparator: Lopinavir/Ritonavir |
Drug: Lopinavir/Ritonavir
2 tablets twice a day
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00632970
Locations
| United States, District of Columbia | |
| George Washington University Medical Faculty Associates | |
| Washington DC, District of Columbia, United States, 20037 | |
Sponsors and Collaborators
George Washington University
Investigators
| Principal Investigator: | Gary Simon, MD, PhD | George Washington University |
More Information
No publications provided
| Responsible Party: | Gary Simon, MD PhD, George Washington University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00632970 History of Changes |
| Other Study ID Numbers: | GS001 |
| Study First Received: | February 29, 2008 |
| Last Updated: | July 7, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by George Washington University:
|
Raltegravir Lopinavir |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Ritonavir |
Lopinavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013