ABOUT THIS STUDY
- The patient has signed and dated approved informed consent form.
- There is confirmed laboratory diagnosis of HIV infection (positive ELISA HIV antibody test confirmed by Western blot, p24 antigen assay, quantitative HIV-1 RNA assay, or HIV culture).
- The patient is at least 18 years of age.
- ART-naïve, lopinavir/ritonavir susceptible on genotypic testing, CCR5-tropic virus on Trofile testing (ESTA).
- Negative pregnancy test within 72 hours prior to start of study for women of childbearing potential.
- Females of childbearing potential and males must utilize effective barrier contraception.
- HIV RNA greater than 1,000 copies per mL at entry.
- Liver enzymes (AST, ALT) < 3 times the upper limit of normal.
- Patients who are pregnant or breast-feeding.
- Active alcohol or substance abuse sufficient, in the Investigator's opinion that makes
compliance to the study protocol unlikely.
- Suspected or active HIV-related opportunistic infection or condition requiring acute
therapy within 30 days of entry into the trial.
- Patients on therapy for hepatitis B.
- Patients with hepatitis B surface antigen, or any evidence of active hepatitis B such
as positive hepatitis B DNA and/or presence of hepatitis e antigen or e antibody.
- Acute hepatitis B or C within 60 days of entry.
- Patients harboring preexistent co-receptor CXCR4 tropic or dual-or mixed-tropic HIV.
- Patients harboring HIV resistant to lopinavir/ritonavir on genotypic testing.
- The presence of decompensated heart failure, myocardial infarction within 1 year,
bypass surgery, severe vascular disease, or active hepatobiliary disease.
- Concomitant use of rifampin, ergot derivatives (i.e. dihydroergotamine, ergotamine),
cisapride, lovastatin, simvastatin, triazolam, orally administered midazolam,
carbamazepine, phenytoin, St. John's wort, ketoconazole, itraconazole, clarithromycin,
telithromycin, amiodarone, bepridil, flecainide, propafenone, quinidine, voriconazole
- Patients with concomitant diagnosis of malignancy or cancer other than basal cell
carcinoma within the past 5 years.
- Concomitant use of investigational agents including the use of any investigational
- Any other clinical conditions or prior therapy that, in the opinion of the
investigator, would make the patient unsuitable for study, or unable to comply with
the dosing requirements.
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Honolulu, Hawaii
- Philadelphia, Pennsylvania
- New York, New York