Safety of Lopinavir/Ritonavir (Kaletra) in HIV/HCV Co-infected Subjects vs Baseline Liver Biopsy Metavir Score
![]() |
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: NCT00234975 |
Recruitment Status
:
Completed
First Posted
: October 10, 2005
Last Update Posted
: January 3, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infection | Drug: Lopinavir/Ritonavir | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 86 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Evaluation of Clinical Response and Safety in HIV Positive Subjects Co-infected With Hepatitis C Treated With a Kaletra Containing HAART Regimen |
Study Start Date : | October 2002 |
Actual Primary Completion Date : | January 2008 |
Actual Study Completion Date : | January 2008 |

Arm | Intervention/treatment |
---|---|
Active Comparator: HCV + |
Drug: Lopinavir/Ritonavir
400 mg/ 100 mg BID. Both arms use Kaletra 400/100 mg BID, plus NRTI chosen by the investigator
Other Name: ABT-378, lopinavir/ritonavir, Kaletra
|
Active Comparator: HCV - |
Drug: Lopinavir/Ritonavir
400 mg/ 100 mg BID. Both arms use Kaletra 400/100 mg BID, plus NRTI chosen by the investigator
Other Name: ABT-378, lopinavir/ritonavir, Kaletra
|
- Primary Outcome Measure [ Time Frame: Baseline, Week 4, Week 8, Week 16 and Week 24 ]Changes in liver functions enzyme.
- Secondary Outcome Measures [ Time Frame: Baseline, Week 4, Week 8, Week 16 and Week 24 ]Changes in HIV viral load, CD4/CD8 cell count, and Hepatitis C viral load

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: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Documented HIV positive.
- At least 18 years of age.
- Does not exhibit evidence of acute illness (especially any acute liver disease, except hepatitis C)
- Subject has not been treated for an active opportunistic infection within 30 days of the baseline visit.
- Subject Has a Karnofsky Score greater than or equal to 70.
- Subject does not require and agrees not to take, for the duration of the study, any of the following medications that are contraindicated with Kaletra: astemizole, terfenadine, midazolam, triazolam, cisapride, certain ergot derivatives (ergotamine, dihydroergotamine, ergonovine, and methylergonovine), pimozide, propafenone and flecainide. Rifampin, a potent enzyme inducer, should not be administered with the study medication, because of the possibility of significant decreases in Kaletra concentration during concurrent administration.
- The subject agrees not to take any medication, including over-the-counter medicine, alcohol, recreational drugs or herbal preparations without the knowledge and permission of the principal investigator.
- Subject had laboratory testing within the previous three months and the most recent testing demonstrates all of the following: Hemoglobin> 8.0 g/dL; absolute neutrophil count > 750 cells/mL; Platelet count > 20,000/mL; ALT or AST </=10 x upper limit of normal (ULN); Creatinine< 1.5 x ULN; Triglycerides </=750 mg/dL.
- Subjects have no evidence of grade III or IV adverse event or laboratory abnormality (except for LFTs).
Exclusion Criteria:
No exclusion criteria.

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): NCT00234975
Puerto Rico | |
Site Reference ID/Investigator# 4118 | |
Bayamon, Puerto Rico, 00960 | |
Site Reference ID/Investigator# 4119 | |
Bayamon, Puerto Rico, 00961 | |
Site Reference ID/Investigator# 6298 | |
Juana Diaz, Puerto Rico, 00795 | |
Site Reference ID/Investigator# 6284 | |
Las Piedras, Puerto Rico, 00771 | |
Site Reference ID/Investigator# 4101 | |
Mayaguez, Puerto Rico, 00680 | |
Site Reference ID/Investigator# 4116 | |
Playa de Ponce, Puerto Rico, 00731 | |
Site Reference ID/Investigator# 4117 | |
Ponce, Puerto Rico, 00717-1563 | |
Site Reference ID/Investigator# 4099 | |
Ponce, Puerto Rico, 00731 | |
Site Reference ID/Investigator# 4086 | |
Rio Piedras, Puerto Rico, 00926 | |
Site Reference ID/Investigator# 4080 | |
San Juan, Puerto Rico, 00908 | |
Site Reference ID/Investigator# 4100 | |
Santurce, Puerto Rico, 00909 |
Study Director: | Carlos R Rivera-Vazquez, MD | AbbVie |
Additional Information:
Responsible Party: | AbbVie (prior sponsor, Abbott) |
ClinicalTrials.gov Identifier: | NCT00234975 History of Changes |
Other Study ID Numbers: |
PUER-02-003 |
First Posted: | October 10, 2005 Key Record Dates |
Last Update Posted: | January 3, 2013 |
Last Verified: | January 2013 |
Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Lopinavir Ritonavir Phase 4 HIV |
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 Protease 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 |