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| Sponsors and Collaborators: |
Georgetown University GlaxoSmithKline |
|---|---|
| Information provided by: | Georgetown University |
| ClinicalTrials.gov Identifier: | NCT00727597 |
Purpose
The hope of this study is to gather data and information about the tolerability and effectiveness of Lexiva versus Sustiva in patients who have have been generally underrepresented in clinical trials.
| Condition | Intervention | Phase |
|---|---|---|
|
Human Immunodeficiency Virus Infections |
Drug: Lexiva + Norvir + Epzicom Drug: Sustiva + Epzicom |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Study in Underrepresented Patient Population or Regimen Tolerability: SUPPoRT |
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).
|
Drug: Lexiva + Norvir + Epzicom
Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
|
|
B: Experimental
QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
|
Drug: Sustiva + Epzicom
QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
|
The objective of this study is to gain tolerability and efficacy data for Norvir-boosted Lexiva versus Sustiva, both used in combination with Epzicom, as components of a first-line, once daily regimen for the treatment of HIV-1 infection in a patient population that is underrepresented in US clinical research.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
INC7 Either gender is eligible, but enrollment of at least two female subjects to every one male subject is strongly encouraged. A female subject is eligible to participate in the study if she is of:
a. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal); or, b. Childbearing potential with a negative pregnancy test at screen and agrees to use one of the following methods of contraception (any contraception method must be used consistently and correctly, i.e., in accordance with both the Prescribing Information and the instructions of a physician): i. Agreement for complete abstinence from intercourse from 2 weeks prior to administration of investigational products, throughout the study, and for 2 weeks after discontinuation of all study medications; ii. Double barrier contraception (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide); iii. Any intrauterine device (IUD) with published data showing that the expected failure rate is less than 1% per year (not all IUDs meet this criterion); iv. Any other method with published data showing that the lowest expected failure rate for the method is less than 1% per year. Note: Hormonal contraception is not recommended for use in conjunction with Lexiva due to decreased efficacy of contraception as well as increased risk of hepatic transaminase elevation. All applicable Prescribing Information should be consulted.
v. Sterilization (female subject or male partner of female subject)
Exclusion Criteria:
EXC3 Requirement for active treatment for hepatitis C virus infection, as indicated by both a positive HCV serology AND either:
Contacts and Locations| Contact: Karyn Hawkins, RN | 202-687-2294 | hawkinsk@georgetown.edu |
| Contact: Abimael Lopez | 202-687-7387 | al374@georgetown.edu |
| United States, District of Columbia | |
| Georgetown University | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Karyn Hawkins, RN 202-687-2294 hawkinsk@georgetown.edu | |
| Principal Investigator: Princy N Kumar, MD | |
| Principal Investigator: | Princy Kumar, MD | Georgetown University |
More Information
| Responsible Party: | Georgetown University ( Princy N. Kumar, MD ) |
| Study ID Numbers: | COL 110408 |
| Study First Received: | July 31, 2008 |
| Last Updated: | August 1, 2008 |
| ClinicalTrials.gov Identifier: | NCT00727597 History of Changes |
| Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
|
Virus Diseases Efavirenz Sexually Transmitted Diseases, Viral Fosamprenavir Ritonavir HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lamivudine Abacavir Retroviridae Infections Immunologic Deficiency Syndromes |
|
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |