Kaletra-isentress Treatment Evaluation

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

Summary

This study will examine the effectiveness and safety of raltegravir (isentress) when used together with lopinavir/ritonavir (kaletra) for the treatment of HIV-infection. Isentress is a recently, Food and Drug Administration (FDA) approved, HIV medication that has strong effects against the HIV virus. Isentress has been shown in other studies to be safe and well tolerated by HIV patients. Combining this drug with kaletra might enable us to construct a HIV regimen that does not include the more toxic drugs of the nucleoside reverse transcriptase inhibitor class.

Eligible volunteers will undergo the following as part of the study procedure:

1. Sign the study consent form and the HIPAA Authorization Form.

2. Two-third of subjects, the intervention group (selected by random chance) will have their HIV drug treatment changed to kaletra + isentress.

3. The other one-third will continue their usual HIV medications (this will be the control group).

4. Make 9 study related visits to the Ponce clinic during the 48 weeks study period. During these visits, medical information will be collected, and blood tests will be performed.

5. Perform Dexa-scan on two separate occasions at Emory University Hospital Radiology.

Information collected will be used to assess the effectiveness of this treatment in keeping the HIV virus suppressed, how well these two drugs together is tolerated by HIV-infected patients, and the blood levels of these two drugs when given together.

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

Details

• Lead Sponsor: Emory University
• Collaborators: Abbott; Merck Sharp & Dohme Corp.
• Treatments: Anti-Retroviral Agents; Lopinavir; Raltegravir Potassium; Ritonavir

Criteria

Inclusion Criteria:

• HIV-1-infected individuals receiving HAART regimen (if on PI-based regimen, must be 1st PI-containing HAART).

• They must have been on and tolerating current HAART regimen for > 6-months.

• Plasma HIV-1 viral load < 50 copies/ml at study entry.

• Men and women age > 18 years (sex is defined as sex at birth).

• Laboratory values obtained within 30 days prior to study entry:

• Hemoglobin > 9.4 g/dl

• Creatinine < 2 mg/dl

• AST (SGOT) < 2 x ULN

• ALT (SGPT) < 2 x ULN

• Ability and willingness of subject or legal guardian/representative to give written informed consent.

• No CD4 T-cell counts requirement

Exclusion Criteria:

• Subjects with a history of previous intolerance to or virological failure to LPV/r

• Concomitant drugs (including alternative therapies) that may affect PI or RAL plasma concentrations (inducers or inhibitors of the CYP 3A4 or UDP-glucuronosyltransferase iso-enzymes).

• A known history of noncompliance with medications or a known history of noncompliance with scheduled physician and clinic visits.

• Investigational ARV drug.

• Pregnancy/Breast feeding.

• HBV-coinfected patients receiving nucleoside analogue for both HIV and HBV suppression.

• Active drug or alcohol use or dependence which, in the Investigator's opinion, may interfere with adherence to study requirements or endanger subject's health while on the study.

• Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to the screening visit.