A Study to Compare Two Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Previously Received Anti-HIV Treatment
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00004581 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: February 20, 2009
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Lopinavir/Ritonavir Drug: Nevirapine | Phase 3 |
Patients receive 1 of the following:
- ABT-378/RTV plus NVP plus 2 NRTIs; or
- Investigator-selected PI(s) plus NVP plus 2 NRTIs.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 300 participants |
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 |


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, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004581

ClinicalTrials.gov Identifier: | NCT00004581 History of Changes |
Other Study ID Numbers: |
285D M98-888 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | February 20, 2009 |
Last Verified: | February 2009 |
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 |