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ABT-378/Ritonavir and Efavirenz in HIV-Infected Patients Who Have Taken More Than One Protease Inhibitor in the Past

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lopinavir/Ritonavir
Efavirenz
Sponsored by
ViRx
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV Protease Inhibitors, Ritonavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, ABT 378, efavirenz

Eligibility Criteria

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

Inclusion Criteria Patients may be eligible for this study if they: Are HIV-positive. Have a viral load (level of HIV in the blood) of at least 1,000 copies/ml. Have been receiving stable (no changes) anti-HIV treatment that includes at least 1 PI for at least 8 weeks prior to study entry. Have received more than 1 PI for at least 12 weeks each at some time in the past. Exclusion Criteria Patients will not be eligible for this study if they: Have had any active opportunistic (AIDS-related) infections within the past 30 days. Have ever received nonnucleoside reverse transcriptase inhibitors (NNRTIs), such as delavirdine, nevirapine, or efavirenz. Have received certain medications. Are pregnant or breast-feeding. Abuse alcohol or drugs.

Sites / Locations

  • ViRx Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
ViRx
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1. Study Identification

Unique Protocol Identification Number
NCT00004582
Brief Title
ABT-378/Ritonavir and Efavirenz in HIV-Infected Patients Who Have Taken More Than One Protease Inhibitor in the Past
Official Title
A Phase II Study of ABT-378/Ritonavir and Efavirenz in Multiple Protease Inhibitor-Experienced Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
August 2000
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
ViRx

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to see if ABT-378/ritonavir plus efavirenz is safe and effective in lowering the amount of HIV in the blood of patients who have been treated with more than 1 protease inhibitor (PI).
Detailed Description
All patients take ABT-378/ritonavir and efavirenz; there are no placebos in this study. Patients take study medications for 48 weeks, during which time there will be 15 study visits. There is a possibility of a study extension after 48 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV Protease Inhibitors, Ritonavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, ABT 378, efavirenz

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lopinavir/Ritonavir
Intervention Type
Drug
Intervention Name(s)
Efavirenz

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients may be eligible for this study if they: Are HIV-positive. Have a viral load (level of HIV in the blood) of at least 1,000 copies/ml. Have been receiving stable (no changes) anti-HIV treatment that includes at least 1 PI for at least 8 weeks prior to study entry. Have received more than 1 PI for at least 12 weeks each at some time in the past. Exclusion Criteria Patients will not be eligible for this study if they: Have had any active opportunistic (AIDS-related) infections within the past 30 days. Have ever received nonnucleoside reverse transcriptase inhibitors (NNRTIs), such as delavirdine, nevirapine, or efavirenz. Have received certain medications. Are pregnant or breast-feeding. Abuse alcohol or drugs.
Facility Information:
Facility Name
ViRx Inc
City
San Francisco
State/Province
California
ZIP/Postal Code
94103
Country
United States

12. IPD Sharing Statement

Learn more about this trial

ABT-378/Ritonavir and Efavirenz in HIV-Infected Patients Who Have Taken More Than One Protease Inhibitor in the Past

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