Skip to main content
OpenTrials
Completed

NCT Number: NCT00004581

A Study to Compare Two Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Previously Received Anti-HIV Treatment

The purpose of this study is to compare the safety and effectiveness of 2 anti-HIV drug combinations in HIV-infected patients. Both combinations will include nevirapine (NVP), 2 nucleoside reverse transcriptase inhibitors (NRTIs), and at least 1 protease inhibitor (PI). One combination will include a new protease inhibitor, ABT-378, combined in a capsule with ritonavir (RTV).

Completed

Looking for future studies?

Notify Me

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

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royal Brisbane Hosp, Herston, Australia

Loading trial locations.

About this study

Patients receive 1 of the following:

  • ABT-378/RTV plus NVP plus 2 NRTIs; or
  • Investigator-selected PI(s) plus NVP plus 2 NRTIs.

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 at least 12 years old.
  • Are HIV-positive and have a viral load (level of HIV in the blood) of 1,000 - 100,000 copies/ml.
  • Are currently taking an anti-HIV drug combination that includes 1 PI and 2 NRTIs, and that has not been changed in at least 12 weeks.
  • Are naive to (have never taken) at least 1 NRTI, other than zalcitabine or abacavir.
  • Agree to abstinence or use of an effective barrier method (e.g., condom) of birth control.

Exclusion criteria

Patients will not be eligible for this study if they:

  • Have an active illness.
  • Have received treatment for any active opportunistic (AIDS-related) infection within 30 days of study entry.
  • Have ever received a nonnucleoside reverse transcriptase inhibitor (NNRTI).
  • Have received investigational (not yet approved by the FDA) drugs within 30 days of study entry.
  • Have received treatment with a PI other than their current PI.
  • Are receiving chemotherapy for cancer.
  • Are pregnant or breast-feeding.

Treatment and study plan

Lopinavir/ritonavir

Drug

Nevirapine

Drug

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

A Randomized, Open-Label, Phase III Study of ABT-378/Ritonavir in Combination With Nevirapine and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) vs. Investigator Selected Protease Inhibitor(s) in Combination With Nevirapine and Two NRTIs in Antiretroviral-Experienced HIV-Infected Subjects

Important dates

First posted
Aug 31, 2001
Registry last updated
Feb 20, 2009

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.