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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004581

Enrollment

300

Registered

2001-08-31

Start date

Unknown

Completion date

Unknown

Last updated

2009-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Drug Therapy, Combination, Nevirapine, HIV Protease Inhibitors, Ritonavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, ABT 378

Brief summary

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).

Detailed description

Patients receive 1 of the following: 1. ABT-378/RTV plus NVP plus 2 NRTIs; or 2. Investigator-selected PI(s) plus NVP plus 2 NRTIs.

Interventions

DRUGLopinavir/Ritonavir

DRUGNevirapine

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

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.

Countries

Australia, Austria, Brazil, Canada, Denmark, France, Germany, Poland, Puerto Rico, South Africa, Spain, Switzerland, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026