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NCT00004582 Clinical Trial

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

HIV Infections Clinical Trial

Official title:
A Phase II Study of ABT-378/Ritonavir and Efavirenz in Multiple Protease Inhibitor-Experienced Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004582
Other study ID # 285E
Secondary ID M98-957
Status Completed
Phase Phase 2
First received November 2, 1999
Last updated June 23, 2005

Study information
Verified date August 2000
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lopinavir/Ritonavir

• Efavirenz

Locations
Country Name City State
United States ViRx Inc San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
ViRx

Country where clinical trial is conducted

United States, 

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