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| Sponsor: | Denver Infectious Disease Consultants, PLLC |
|---|---|
| Collaborator: |
GlaxoSmithKline |
| Information provided by: | Denver Infectious Disease Consultants, PLLC |
| ClinicalTrials.gov Identifier: | NCT00740064 |
Purpose
To evaluate the efficacy and safety of Raltegravir and Epzicom over 48 weeks in ART-naive HIV-infected subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Raltegravir and Abacavir/Lamivudine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study of Highly Active Antiretroviral Therapy Using Isentress (Raltegravir) and Epzicom (Abacavir/Lamivudine) in Antiretroviral Naive HIV-Infected Subjects |
| Estimated Enrollment: | 30 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | November 2009 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Virologic failure (VF) is defined as having either virologic non-response or virologic rebound. Virologic failure is confirmed by having 2 consecutive plasma HIV-1 RNA levels taken at least 2 weeks apart according to the following definitions:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Screening laboratory values:
Exclusion Criteria:
Contacts and Locations| United States, Arizona | |
| Spectrum Medical Group | |
| Phoenix, Arizona, United States, 85012 | |
| United States, Colorado | |
| Denver Infectious Disease Consultants, PLLC | |
| Denver, Colorado, United States, 80220 | |
| United States, New Mexico | |
| Southwest CARE Center | |
| Santa Fe, New Mexico, United States, 87505-4765 | |
| Principal Investigator: | Benjamin Young, MD, PhD | Denver Infectious Disease Consultants, PLLC |
More Information
| Responsible Party: | Benjamin Young, MD, PhD, Denver Infectious Disease Consultants, PLLC |
| ClinicalTrials.gov Identifier: | NCT00740064 History of Changes |
| Other Study ID Numbers: | COL111429 |
| Study First Received: | August 20, 2008 |
| Last Updated: | January 27, 2009 |
| Health Authority: | United States: Institutional Review Board |
|
HIV infections |
|
HIV Infections Acquired Immunodeficiency Syndrome 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 Lamivudine |
Abacavir Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |