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

NCT ID: NCT00632970

Last Updated: 2018-08-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2010-06-30

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.

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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Raltegravir

Intervention Type: DRUG

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

Truvada

Intervention Type: DRUG

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

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)

Group Type: ACTIVE_COMPARATOR

Lopinavir/Ritonavir

Intervention Type: DRUG

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

Truvada

Intervention Type: DRUG

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

Interventions

Raltegravir

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

Intervention Type: DRUG

Lopinavir/Ritonavir

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

Intervention Type: DRUG

Truvada

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

Intervention Type: DRUG

Other Intervention Names

Isentress; Kaletra; Emtricitabine/Tenofovir disoproxil fumarate

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

George Washington University

OTHER

Sponsor Role: lead

Responsible Party

Gary Simon

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gary Simon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

George Washington University

Locations

George Washington University Medical Faculty Associates

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

Countries

United States

Other Identifiers

GS001

Identifier Type: -

Identifier Source: org_study_id