- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005017
Effectiveness and Safety of Epivir/Ziagen/Zerit (3TC/ABC/d4T) Versus Epivir/Ziagen/Sustiva (3TC/ABC/EFV) Versus Epivir/Ziagen/Agenerase/Norvir (3TC/ABC/APV/RTV) in HIV Patients Who Have Never Received Treatment
A Phase IV, Open-Label, Randomized Study to Compare the Efficacy and Safety of Epivir/Ziagen/Zerit (3TC/ABC/d4T) Versus Epivir/Ziagen/Sustiva (3TC/ABC/EFV) Versus Epivir/Ziagen/Agenerase/Norvir (3TC/ABC/APV/RTV) for 96 Weeks in the Treatment of HIV-1 Infected Subjects Who Are Antiretroviral Therapy Naive
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients are randomized to initiate antiretroviral therapy in 1 of 3 treatment groups. Within each group they are stratified based on HIV-1 plasma RNA levels.
Group 1: Patients receive 3TC/ABC/d4T; Group 2: Patients receive 3TC/ABC/EFV; and Group 3: Patients receive 3TC/ABC/APV/RTV.
Treatment continues for 96 weeks. Blood samples are collected to measure plasma HIV RNA and CD4 counts and patients are assessed regularly. In the event of incomplete viral suppression or virologic failure, patients will be switched to secondary therapy.
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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North Carolina
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Research Triangle Park, North Carolina, United States, 27709
- Jaime Hernandez
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Patients may be eligible for this trial if they:
- Are HIV-positive.
- Are at least 18 years old.
- Have a viral load of at least 5,000 copies/ml.
- Have a CD4 count of at least 50 cells/mm3.
- Agree to practice effective methods of birth control while on the study, if a woman.
Patients are not eligible for this trial if they:
Are pregnant or breast-feeding. Have ever taken anti-HIV drugs. (Less than 2 weeks of prior anti-HIV treatment is allowed.) Have a history of AIDS-defining opportunistic illness (except for Kaposi's sarcoma involving skin) within 45 days of the screening visit. Treatment for the illness must have been completed at least 30 days prior to screening.
Are enrolled in another study where the medication may interfere with the control of viral load in this study.
Have a serious medical condition such as diabetes or heart problems that would make it unsafe to be on this study.
Have a history of a severe nerve disease of the type that may cause muscle weakness.
Have had pancreatitis (inflamed pancreas) or hepatitis within 6 months of starting the study.
Have had radiation treatment or chemotherapy within 4 weeks prior to study entry, or think those treatments may be needed during the study period. Local treatment for Kaposi's sarcoma is allowed.
Have used certain medications, including vaccines, that interfere with the immune system within 4 weeks prior to study entry.
Have taken an HIV vaccine within 3 months prior to entry. Are taking St. John's wort. Have a history of being allergic to any of the study drugs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Protease Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Antitubercular Agents
- Antibiotics, Antitubercular
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 CYP2C9 Inhibitors
- Cytochrome P-450 CYP2C19 Inhibitors
- Ritonavir
- Lamivudine
- Stavudine
- Efavirenz
- Abacavir
- Amprenavir
Other Study ID Numbers
- 264N
- ESS40001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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