HIV Infections
Conditions
Keywords
Raltegravir, Lopinavir
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.
Interventions
DRUGRaltegravir
1, 400mg tablet twice a day, with Truvada 1 tablet once a day
DRUGLopinavir/Ritonavir
2 tablets twice a day, with Truvada 1 tablet once a day
DRUGTruvada
1 tablet, once a day, with either Raltegravir (Isentress) or Lopinavir/Ritonavir(Kaletra)
Sponsors
George Washington University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute Change in CD4 Cell Counts | 24 and 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change is Plasma Lipids, Lipoproteins and Lipoprotein Subtypes. | 24 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Raltegravir Raltegravir: 1 400mg tablet twice a day | 3 |
| Lopinavir/Ritonavir Lopinavir/Ritonavir: 2 tablets twice a day | 3 |
| Total | 6 |
Baseline characteristics
| Characteristic | Lopinavir/Ritonavir | Total | Raltegravir |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 6 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 6 Participants | 3 Participants |
| HIV seropositive with viral load < 10,000 | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 3 Participants | 1 Participants |
| Region of Enrollment United States | 3 participants | 6 participants | 3 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 |
Outcome results
Primary
Absolute Change in CD4 Cell Counts
Time frame: 24 and 48 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir | Absolute Change in CD4 Cell Counts | 50 cells/mm^3 |
| Lopinavir/Ritonavir | Absolute Change in CD4 Cell Counts | 50 cells/mm^3 |
Secondary
Change is Plasma Lipids, Lipoproteins and Lipoprotein Subtypes.
Time frame: 24 weeks
Population: Data can not be reported because the samples were never analyzed and therefore no data was analyzed.