Raltegravir vs. Lopinavir/Ritonavir, Both in Combination With Truvada, in HIV+ Treatment Naive Individuals
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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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Raltegravir Drug: Lopinavir/Ritonavir Drug: Truvada | Phase 4 |
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 |
Actual Primary Completion Date : | February 2010 |
Actual Study Completion Date : | June 2010 |

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
|
- Absolute Change in CD4 Cell Counts [ Time Frame: 24 and 48 weeks ]
- Change is Plasma Lipids, Lipoproteins and Lipoprotein Subtypes. [ Time Frame: 24 weeks ]

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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:
- 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.

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 |
Principal Investigator: | Gary Simon, MD, PhD | George Washington University |
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:
Raltegravir Lopinavir |
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 Ritonavir Lopinavir Tenofovir Raltegravir Potassium Emtricitabine 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 |