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| Sponsor: | Therapeutic Concepts |
|---|---|
| Information provided by: | Therapeutic Concepts |
| ClinicalTrials.gov Identifier: | NCT00116636 |
Purpose
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 |
Eligibility| 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:
Contacts and Locations| 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. |
More Information
| Study ID Numbers: | 70-1002-064 |
| Study First Received: | June 29, 2005 |
| Last Updated: | July 18, 2005 |
| ClinicalTrials.gov Identifier: | NCT00116636 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
HIV Treatment Naive |
|
Anti-Infective Agents HIV Protease Inhibitors RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Infection Antiviral Agents |
Pharmacologic Actions Immunologic Deficiency Syndromes Protease Inhibitors Virus Diseases Anti-Retroviral Agents Lopinavir HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |