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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

Primary Purpose

HIV Infections

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ritonavir
Abacavir sulfate
Amprenavir
Efavirenz
Lamivudine
Stavudine
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, Ritonavir, Lamivudine, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, abacavir, efavirenz

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jaime Hernandez

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 3, 2000
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00005017
Brief Title
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
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
June 2001
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Glaxo Wellcome

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to see how effective and safe it is to give 1 of the 3 following treatments to patients who may not have received anti-HIV treatment: 1) lamivudine (3TC)/abacavir (ABC)/stavudine (d4T); 2) 3TC/ABC/efavirenz (EFV); or 3) 3TC/ABC/amprenavir (APV)/ritonavir (RTV).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, Ritonavir, Lamivudine, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, abacavir, efavirenz

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ritonavir
Intervention Type
Drug
Intervention Name(s)
Abacavir sulfate
Intervention Type
Drug
Intervention Name(s)
Amprenavir
Intervention Type
Drug
Intervention Name(s)
Efavirenz
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Stavudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Jaime Hernandez
City
Research Triangle Park
State/Province
North Carolina
ZIP/Postal Code
27709
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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