A Study to Compare Two Anti-HIV Drug Combinations That Include Amprenavir in HIV-Infected Patients Who Have Failed Anti-HIV Drug Combinations That Did Not Include Amprenavir
This study has been completed.
Sponsor:
Glaxo Wellcome
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002423
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1999
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Purpose
This study will compare the safety and effectiveness of two anti-HIV drug combinations in fighting HIV infection in patients whose viral loads (levels of HIV in the blood) rose with other anti-HIV drug treatments.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Indinavir sulfate Drug: Abacavir sulfate Drug: Amprenavir Drug: Nelfinavir mesylate Drug: Lamivudine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
| Official Title: | A Phase II, Open-Label Trial for Treatment of HIV Infection in Subjects Who Have Failed Initial Combination Therapy With Regimens Containing Indinavir or Nelfinavir: Combination Therapy With 3TC (150 Mg BID), Abacavir (300 Mg BID) and Amprenavir (1200 Mg BID) Plus Either Nelfinavir (1250 Mg BID) or Indinavir (800 Mg TID) for 48 Weeks |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Sulfate ion
Lamivudine
Abacavir
Indinavir
Indinavir sulfate
Nelfinavir
Nelfinavir Mesylate
Amprenavir
Abacavir sulfate
U.S. FDA Resources
Further study details as provided by NIH AIDS Clinical Trials Information Service:
| Estimated Enrollment: | 100 |
| Study Start Date: | March 1999 |
Patients experiencing virologic failure while receiving an IDV-containing antiretroviral regimen will receive the 3TC/ABC/APV/NFV combination. Patients experiencing virologic failure while receiving an NFV-containing antiretroviral regimen will receive the 3TC/ABC/APV/IDV combination.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
You may be eligible for this trial if you:
- Are HIV-positive.
- Are 13 years of age or older.
- Are currently taking anti-HIV drugs, 1 of which must be NFV or IDV, and have taken these same drugs for at least 12 weeks.
- In the last 16 weeks your viral load (level of HIV in the blood) dropped below 400 copies/ml and has since increased to at least 1,000 copies/ml, even though you continue to take your anti-HIV drugs.
- Have the written consent of a parent or legal guardian if you are under age 18.
- Agree to practice abstinence or use effective barrier methods of birth control (unless you are physically incapable of becoming pregnant).
- Are willing to complete the 48-week study.
Exclusion Criteria
You will not be eligible for this trial if you:
- Have ever taken the following anti-HIV drugs: ABC, APV, efavirenz (EFV), delavirdine (DLV), nevirapine (NVP), or loviride.
- Have certain AIDS-related infections or diseases, have other serious medical conditions such as diabetes and certain types of heart trouble, or have a history of lymphoma.
- Have had certain types of hepatitis in the past 6 months.
- Have received an HIV vaccine in the past 3 months or a flu vaccine in the past 30 days.
- Have certain digestion problems that make it difficult to take anti-HIV drugs by mouth.
- Have received certain other drugs or treatments in the past 30 days, or will need certain drugs or treatments during the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002423
Locations
| United States, California | |
| Saint Francis Mem Hosp | |
| San Francisco, California, United States, 94109 | |
| United States, District of Columbia | |
| Georgetown Univ Med Ctr | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| IDC Research Initiative | |
| Altamonte Springs, Florida, United States, 32701 | |
| United States, Maryland | |
| Natl Institute of Allergy and Infectious Diseases | |
| Bethesda, Maryland, United States, 20892 | |
| United States, Missouri | |
| Kansas City AIDS Research Consortium | |
| Kansas City, Missouri, United States, 64111 | |
| United States, New York | |
| Bentley-Salick Med Practice | |
| New York, New York, United States, 10011 | |
| United States, Oklahoma | |
| Associates in Med and Mental Health | |
| Tulsa, Oklahoma, United States, 74114 | |
| United States, Oregon | |
| Portland Veterans Adm Med Ctr / Rsch & Education Grp | |
| Portland, Oregon, United States, 972109951 | |
Sponsors and Collaborators
Glaxo Wellcome
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002423 History of Changes |
| Other Study ID Numbers: | 264M, PRO20005 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
Drug Therapy, Combination HIV Protease Inhibitors Lamivudine Indinavir Nelfinavir |
VX 478 Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load abacavir |
Additional relevant MeSH terms:
|
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 HIV Protease Inhibitors Indinavir Nelfinavir Amprenavir |
Lamivudine Reverse Transcriptase Inhibitors Abacavir Anti-HIV Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Nucleic Acid Synthesis Inhibitors Antibiotics, Antitubercular Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 16, 2013