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OpenTrials
Completed

NCT Number: NCT00004582

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

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).

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

0 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ViRx Inc

San Francisco, California, 94103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lopinavir/ritonavir

Drug

Efavirenz

Drug

Sponsors and collaborators

Lead sponsor

ViRx

Industry

Registry information

Official study title

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

Important dates

First posted
Aug 31, 2001
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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