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Sponsored by: |
Therapeutic Concepts |
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Information provided by: | Therapeutic Concepts |
ClinicalTrials.gov Identifier: | NCT00116636 |
Expected Enrollment: 40 patients
Study Start Date: June 2005
Study Objectives:
Primary Objectives:
Secondary Objectives:
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Kaletra |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment |
Official Title: | A Phase II, Open Label, Single Arm Study of the 48-Week Virologic and Immunologic Response to Lopinavir/Ritonavir (Kaletra) as a Single Agent in a Cohort of HIV Positive Adult Patients |
Estimated Enrollment: | 40 |
Study Start Date: | June 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
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:
Contact: Joseph C. Gathe, M.D. | 713-526-9821 | drgathe@josephgathe.com |
Contact: Deborah H. Lemons, B.S. | 713-526-9821 ext 214 | dlemons@josephgathe.com |
United States, Texas | |
Therapeutic Concepts, P.A. | Recruiting |
Houston, Texas, United States, 77004 | |
Contact: Joseph C. Gathe, M.D. 713-526-9821 drgathe@josephgathe.com | |
Contact: Deborah H. Lemons, B.S. 713-526-9821 dlemons@josephgathe.com | |
Principal Investigator: Joseph C. Gathe, M.D. |
Principal Investigator: | Joseph C. Gathe, M.D. | Therapeutic Concepts, P.A. |
Study ID Numbers: | 70-1002-064 |
Study First Received: | June 29, 2005 |
Last Updated: | July 18, 2005 |
ClinicalTrials.gov Identifier: | NCT00116636 |
Health Authority: | United States: Institutional Review Board |
HIV Treatment Naive |
Virus Diseases Sexually Transmitted Diseases, Viral Lopinavir HIV Seropositivity Ritonavir |
HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections HIV Protease Inhibitors Slow Virus Diseases Anti-HIV Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Protease Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections |