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

NCT00268827 | Completed Phase 4 DMC

• 2 other identifiers: 70-1002-070371-11-05
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV-1; AIDS

Keywords

Kaletra; Comparison; Quality of Life; African American

Outcome Measures

Primary Outcomes (1)

• To compare the tolerability and acceptance of patients on the Kaletra® soft gel with that of Kaletra® tablet formulation utilizing the Symptoms Distress Module developed by the ACTG and the Center Epidemiological S

Secondary Outcomes (1)

• Proportion of subjects maintaining or achieving HIV-RNA < 400 or < 50 copies/ml, maintaining or increasing CD4 T-lymphocyte count;G.I. or other adverse events grade 2-4;Other adverse events

Interventions

Kaletra soft-gel capsules switched to Kaletra tablets DRUG

MOS-HIV Health and Medication Satisfaction Survey, Global Conditioning Improvement and Therapy Preference Questionnaire DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.
• \. Patient requires inhaled or intranasal fluticasone

Sponsors & Collaborators

• AIDS Arms Inc.: lead

Study Sites (1)

AIDS Arms Inc./Peabody Health Center

Dallas, Texas, 75215, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Marsden K. Rawlings, MD

  AIDS Arms Inc./Peabody Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 22, 2005
• First Posted: December 23, 2005
• Study Start: December 1, 2005
• Study Completion: February 1, 2006
• Last Updated: April 5, 2007

Record last verified: 2007-04

Locations

US (1)