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

NCT00632970 | Terminated Phase 4 Results DMC

• 1 other identifier: GS001
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

Raltegravir; Lopinavir

Outcome Measures

Primary Outcomes (1)

• Absolute Change in CD4 Cell Counts

  24 and 48 weeks

Secondary Outcomes (1)

• Change is Plasma Lipids, Lipoproteins and Lipoprotein Subtypes.

  24 weeks

Study Arms (2)

Raltegravir plus Truvada

EXPERIMENTAL

Raltegravir (400mg), 1 tablet, administered twice daily (BID) and Truvada (Emtricitabine/Tenofovir disoproxil fumarate) (200mg/300mg), 1 tablet administered once daily (QD)

Drug: Raltegravir; Drug: Truvada

Lopinavir/Ritonavir plus Truvada

ACTIVE COMPARATOR

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; Drug: Truvada

Interventions

Raltegravir DRUG

1, 400mg tablet twice a day, with Truvada 1 tablet once a day

Also known as: Isentress

Raltegravir plus Truvada

Lopinavir/Ritonavir DRUG

2 tablets twice a day, with Truvada 1 tablet once a day

Also known as: Kaletra

Lopinavir/Ritonavir plus Truvada

Truvada DRUG

1 tablet, once a day, with either Raltegravir (Isentress) or Lopinavir/Ritonavir(Kaletra)

Also known as: Emtricitabine/Tenofovir disoproxil fumarate

Lopinavir/Ritonavir plus Truvada; Raltegravir plus Truvada

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir Potassium; Lopinavir; lopinavir-ritonavir drug combination; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidinones; Pyrimidines; Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Gary Simon
• Organization: Medical Faculty Associates

Gsimon@mfa.gwu.edu

202 741-2234

Study Officials

• Gary Simon, MD, PhD

  George Washington University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 29, 2008
• First Posted: March 11, 2008
• Study Start: February 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: June 1, 2010
• Last Updated: August 29, 2018
• Results First Posted: June 26, 2017

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)