A Comparison Study of Kaletra Soft-Gel Capsules and Kaletra Tablets in an African American Cohort

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare Kaletra tablets with Kaletra soft-gel capsules to see if there is any change in the side effects you may have and to see how people in the study feel about using the tablets.

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

Details

• Lead Sponsor: AIDS Arms Inc.
• Treatments: Lopinavir

Criteria

Inclusion Criteria:1. African American male or female patients ≥ 18 years of age 2. Documented HIV-infected 3. Currently on Kaletra® soft-gel capsules for >2 weeks 4. Competent and willingness to sign and date a written informed consent 5. No recent acute illness in the preceding 30 days which in the opinion of the investigator would preclude inclusion in the study 6. No current gastrointestinal symptoms at baseline of grade II or greater 7. A female is eligible to enter and participate in this study if she is of:

• Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal) or

• Child-bearing potential, has a negative urine or serum pregnancy test at screen, and agrees to one of the following:

• Complete abstinence from intercourse from 2 weeks prior to administration of the study drug, throughout the study, and for at least 2 weeks after completion or premature discontinuation from the study to account for elimination of the investigational drug. Should a patient decide to become sexually active during the course of the study, she must be counseled and be willing to use one of the birth control methods listed below:

• Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide)

• Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year (not all IUDs meet this criterion)

• Sterilization (female patient or male partner of female patient)

• Any other methods with published data showing that the lowest expected failure rate for that method is <1% per year.

NOTE: Data are insufficient to exclude a clinically important interaction of LPV/r with drugs, such as hormonal contraceptives, that are highly metabolized by the cytochrome P450 enzyme system. As a result, hormonal contraception is not considered adequate.

Exclusion Criteria:1. Positive pregnancy test or breast-feeding 2. Known hypersensitivity to study medications 3. Inability to conform to protocol procedures, including alcohol or drug abuse, untreated psychiatric illness 4. An unwillingness or presence of any condition that will impair the ability to swallow medications 5. Patient has required treatment with radiation therapy or cytotoxic chemotherapeutic agents within 4 weeks prior to entry, or has an anticipated need for these agents within the study period.

6. Patient requires treatment with immunomodulating agents, such as systemic corticosteroids, interleukins, or interferon's within 4 weeks prior to study entry, or patients who have received an HIV immunotherapeutic vaccine within 3 months prior to entry.

7. Patient requires inhaled or intranasal fluticasone

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