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

George Washington University (GW)

Status and phase: Terminated; Phase 4

Conditions: HIV Infections

Treatments: Drug: Raltegravir; Drug: Lopinavir/Ritonavir; Drug: Truvada

Study type: Interventional

Funder types: Other

Identifiers

NCT00632970

GS001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Raltegravir plus Truvada

Experimental group

Description:

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

Treatment:

Drug: Truvada

Drug: Raltegravir

Lopinavir/Ritonavir plus Truvada

Active Comparator group

Description:

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)

Treatment:

Drug: Truvada

Drug: Lopinavir/Ritonavir