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