Kaletra and Viread in Antiretroviral Naïve Patients

• Status: Terminated
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Once daily antiretroviral therapy with Viread (tenofovir DF, 300mg) plus Kaletra (LPV/r, 800mg/200mg) will be effective in suppressing and maintaining suppression of HIV RNA to <50 copies/ml in antiretroviral naïve patients through 48 weeks of therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oklahoma State University Center for Health Sciences
• Collaborator: Abbott
• Treatments: Lopinavir; Ritonavir; Tenofovir

Criteria

Inclusion Criteria:

1. Male or female patients >18 years of age with documented HIV-1 infection

2. Naïve to antiretroviral therapy

3. Able and willing to provide written informed consent

4. No CD4 restriction

5. HIV-1 RNA levels >5000 c/mL

6. Female patients must meet these additional criteria

1. Non-childbearing potential

2. Negative serum pregnancy test at screen

3. Willingness to abstain from sexual intercourse or use double barrier contraception

Exclusion Criteria:

1. Presence of any of the following:

1. Aminotransferases >3xULN

2. Hemoglobin concentration <8.0g/dl

3. Absolute neutrophil count <800 cells/cubic mm

4. Platelet count <50,000 cells/cubic mm

5. Acute illness, or an acute illness ≤7 days

6. Presence of Opportunistic Infection, or an OI within 30 days of screening

7. Acute or chronic active Hepatitis B

8. Hepatitis C

9. Creatinine Clearance <50 mL/min

2. Pregnant or breast-feeding women

3. Presence of any illness, physical or behavioral conditions (i.e., substance abuse, excluding cannabis) that will impair the patient's ability participate

4. Patient who, in the opinion of the investigator, will be unlikely to complete the study protocol and adhere to the study drug regimens

5. Concurrent use of medications that may potentially interact with study medications including: astemizole, terfenadine, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, St. John's wort, lovastatin, simvastatin, pimozide, midazolam, triazolam, adefovir, cidofovir, acyclovir, ganciclovir, and valganciclovir.

6. Patient suffers from a serious medical condition that may in the opinion of the investigator compromise his or her safety.