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

Purpose

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).

Condition	Intervention	Phase
HIV Infections	Drug: Lopinavir/Ritonavir Drug: Nevirapine	Phase 3


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS HIV/AIDS Medicines

Drug Information available for: Nevirapine Ritonavir Lopinavir

U.S. FDA Resources

Further study details as provided by Abbott:


Estimated Enrollment:	300

Detailed Description:

Patients receive 1 of the following:

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

Eligibility


Ages Eligible for Study:	12 Years and older (Child, Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004581

Show 88 Study Locations

Sponsors and Collaborators

Abbott

More Information


ClinicalTrials.gov Identifier:	NCT00004581 History of Changes
Other Study ID Numbers:	285D M98-888
Study First Received:	November 2, 1999
Last Updated:	February 19, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:


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

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Lopinavir HIV Protease Inhibitors Nevirapine	Protease Inhibitors Reverse Transcriptase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Nucleic Acid Synthesis Inhibitors Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers

ClinicalTrials.gov processed this record on September 28, 2016