A Pilot Study of Kaletra and Intelence Tablets in Naive Subjects (KALYINTE)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Therapeutic Concepts.
Recruitment status was Recruiting
Information provided by:
First received: January 8, 2010
Last updated: February 12, 2010
Last verified: January 2010
The purpose of this study is to see if using a combination of other drug classes, like the ones that Kaletra® and Intelence™ belong to, can still help reduce the amount of HIV in your blood. Using Kaletra® and Intelence™ without other drugs is not approved by the FDA and so their use in this study is experimental.
Drug: Kaletra and Intelence Tablets
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase IV 48 Week, Open Label, Pilot Study of Kaletra and Intelence Tablets in Naive Subjects
Primary Outcome Measures:
- Proportion of patients with plasma HIV-1 RNA < 400 copies/mL at weeks 24 and 48 [ Time Frame: At weeks 24 and 48 ] [ Designated as safety issue: Yes ]
- Proportion of patients with plasma HIV-1 RNA < 75 copies/mL at weeks 24 and 48 [ Time Frame: At weeks 24 and 48 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Proportion of patients with plasma HIV-1 RNA < 400 copies/mL or < 75 copies/mL at each study visit [ Time Frame: At weeks 24 and 48 ] [ Designated as safety issue: Yes ]
- Number of weeks until HIV RNA < 400 copies/mL and < 75 copies/mL, respectively [ Time Frame: At weeks 24 and 48 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||April 2011 (Final data collection date for primary outcome measure)
Experimental: Kaletra And Intelence
This is a Phase IV, 48-week, open-label, pilot study in 30 ARV-naïve patients examining the safety, viral response, and tolerability of Kaletra® and Intelence™ tablets.
Drug: Kaletra and Intelence Tablets
Kaletra 400 mg twice a day and Intelence Tablets 200mg twice a day.
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- HIV-1 RNA ≥ 5000 copies/mL by Roche Amplicor 1.5v Primer
- More than 18 years of age
- Provide written informed consent and willingness to participate in and comply
- Less than 7 days of prior ART with any licensed or investigational compound
- Does not currently have or has not been treated for an active opportunistic infection (OI) within 30 days of screening
- Vital signs, physical examination and laboratory results do not exhibit evidence of acute illness
- A female who is a non-childbearing potentiator or if in child-bearing potential, has a negative 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 like double barrier method, intrauterine device, sterilization and any other methods.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01045369
|Therapeutic Concepts, PA
|Houston, Texas, United States, 77004 |
|Contact: Bernie A. Miguel 713-526-9821 email@example.com |
|Principal Investigator: Joseph C. Gathe, Jr., MD |
||Joseph C. Gathe, Jr., MD
No publications provided
||Joseph C. Gathe, Jr., MD, Therapeutic Concepts, PA
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 8, 2010
||February 12, 2010
||United States: Institutional Review Board
Keywords provided by Therapeutic Concepts:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 29, 2014
Acquired Immunodeficiency Syndrome
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action