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Study Of Investigational Regimen Combining FDA Approved HIV Drugs In HIV Subjects Experiencing Early Virologic Failure
This study has been completed.
Sponsor:
ViiV Healthcare
Information provided by:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00038506
First received: May 31, 2002
Last updated: April 6, 2015
Last verified: October 2010
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Purpose
This study is a 48-week study to evaluate the efficacy and safety of an investigational regimen combining FDA approved HIV drugs in antiretroviral-experienced subjects failing on their first highly active antiretroviral therapy regimen.
| Condition | Intervention | Phase |
|---|---|---|
| HIV Infection | Drug: abacavir/lamivudine/zidovudine Drug: tenofovir | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | A Phase IV, Open-label, Multicenter Study of Treatment With TRIZIVIR (Abacavir 300mg/Lamivudine 150mg/Zidovudine 300mg) Twice Daily and Tenofovir 300mg Once-daily for 48 Weeks in HIV-infected Subjects Experiencing Early Virologic Failure (ZIAGEN Intensification Protocol) |
Resource links provided by NLM:
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Zidovudine
Lamivudine
Abacavir
Tenofovir
Abacavir sulfate
Tenofovir Disoproxil Fumarate
U.S. FDA Resources
Further study details as provided by ViiV Healthcare:
Primary Outcome Measures:
- HIV viral load response at 48 weeks as measured by proportion of subjects with undetectable viral load. [ Time Frame: 48 weeks ]
Secondary Outcome Measures:
- Safety Viral load response at 24 weeks Change in T-cell count Resistance Health outcomes [ Time Frame: 24 weeks ]
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2002 |
| Study Completion Date: | August 2004 |
| Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: abacavir/lamivudine/zidovudine
Drug: tenofovir
Other Name: abacavir/lamivudine/zidovudine
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Currently on an initial HAART (highly active antiretroviral therapy) regimen of 3TC/ZDV or 3TC/d4T and a PI (protease inhibitor) -boosted or unboosted- or NNRTI (non-nucleoside reverse transcriptase inhibitor).
- Plasma HIV - 1 RNA was <400 copies/ml on at least 2 documented occasions prior to viral rebound.
- Have a plasma HIV - 1 RNA value >400 copies/ml and <10,000 copies/ml on 2 documented successive occasions (including screen) separated by at least 2 weeks.
- A CD4+ lymphocyte count less than or equal to 100.
Exclusion Criteria:
- Have not taken Abacavir (ZIAGEN or TRIZIVIR) or tenofovir (VIREAD) previously.
- Have not had an AIDS defining illness within 30 days of screen.
- Pregnant or breast-feeding.
- Specified viral genotypes upon screening.
- And other inclusion or exclusion criteria to be evaluated by the physician.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00038506
Please refer to this study by its ClinicalTrials.gov identifier: NCT00038506
Locations
| United States, California | |
| GSK Investigational Site | |
| Los Angeles, California, United States, 90027 | |
| GSK Investigational Site | |
| San Rafael, California, United States, 94903 | |
| United States, Florida | |
| GSK Investigational Site | |
| Fort Lauderdale, Florida, United States, 33145 | |
| GSK Investigational Site | |
| Jacksonville, Florida, United States, 32206 | |
| GSK Investigational Site | |
| Lake Worth, Florida, United States, 33463 | |
| GSK Investigational Site | |
| Miami Beach, Florida, United States, 33139 | |
| GSK Investigational Site | |
| Miami, Florida, United States, 33136 | |
| GSK Investigational Site | |
| North Miami, Florida, United States, 33161 | |
| GSK Investigational Site | |
| Orlando, Florida, United States, 32804 | |
| GSK Investigational Site | |
| Tallahassee, Florida, United States, 32303 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Atlanta, Georgia, United States, 30309 | |
| GSK Investigational Site | |
| Decatur, Georgia, United States, 30033 | |
| United States, Illinois | |
| GSK Investigational Site | |
| Chicago, Illinois, United States, 60657 | |
| GSK Investigational Site | |
| Maywood, Illinois, United States, 60153 | |
| United States, Indiana | |
| GSK Investigational Site | |
| Lafayette, Indiana, United States, 47904 | |
| United States, Michigan | |
| GSK Investigational Site | |
| Berkeley, Michigan, United States, 48072 | |
| United States, New York | |
| GSK Investigational Site | |
| Bronx, New York, United States, 10461 | |
| GSK Investigational Site | |
| New York, New York, United States, 10014 | |
| GSK Investigational Site | |
| Valhalla, New York, United States, 10595 | |
| United States, Oklahoma | |
| GSK Investigational Site | |
| Tulsa, Oklahoma, United States, 74114 | |
| United States, Texas | |
| GSK Investigational Site | |
| Arlington, Texas, United States, 76015 | |
| GSK Investigational Site | |
| Dallas, Texas, United States, 75208 | |
| GSK Investigational Site | |
| Dallas, Texas, United States, 75216 | |
| GSK Investigational Site | |
| Dallas, Texas, United States, 75246 | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77004 | |
| United States, Washington | |
| GSK Investigational Site | |
| Seattle, Washington, United States, 98104 | |
| United States, Wisconsin | |
| GSK Investigational Site | |
| Green Bay, Wisconsin, United States, 54301 | |
Sponsors and Collaborators
ViiV Healthcare
Investigators
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | Study Director, GSK |
| ClinicalTrials.gov Identifier: | NCT00038506 History of Changes |
| Other Study ID Numbers: |
ESS 30005 |
| Study First Received: | May 31, 2002 |
| Last Updated: | April 6, 2015 |
Keywords provided by ViiV Healthcare:
|
HIV-1 TRIZIVIR Tenofovir |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Tenofovir Lamivudine Zidovudine |
Abacavir Dideoxynucleosides Lamivudine, zidovudine drug combination Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents Antimetabolites |
ClinicalTrials.gov processed this record on August 21, 2017