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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: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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
| ClinicalTrials.gov Identifier: | NCT00116636 History of Changes |
| Other Study ID Numbers: | 70-1002-064 |
| Study First Received: | June 29, 2005 |
| Last Updated: | July 18, 2005 |
| Health Authority: | United States: Institutional Review Board |
|
HIV Treatment Naive |
|
HIV Infections Acquired Immunodeficiency Syndrome HIV Seropositivity Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Ritonavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |