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Protease Inhibitor

High-Dose Lopinavir/Ritonavir for HIV/AIDS

Q: Are there still opportunities to join this research endeavor?

As indicated on clinicaltrials.gov, this research study is no longer recruiting patients at present. Initially posted in October of 2005 and last edited 18th September 2006, it has since been superseded by 245 other medical trials that are currently accepting participants.

Q: Is enrollment open to individuals aged seventy-five and over for this experiment?

As outlined in the study's specifications, participants must be between 18 and 65 years of age to take part.

Q: Would I be a suitable candidate to join this experiment?

This experiment is accepting 20 people suffering from <a href="https://www.withpower.com/clinical-trials/aids">AIDS</a> that are older than 18. <a href="https://www.withpower.com/clinical-trials/all">All</a> participants must have a body mass index (BMI) between 60 kg and 100 kg in order to qualify.

N/A

Waitlist Available

Led By Harry W. Lampiris, M.D.

Research Sponsored by Lampiris, Harry W., M.D.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

HIV-1 infected males or females at least 18 years of age

Weight > 60 kg and < 100 kg

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying the safety, tolerability, and efficacy of higher doses of lopinavir/ritonavir when taken with other HIV medications, in patients who have not had full viral suppression despite previous treatment.

Who is the study for?

This trial is for HIV/AIDS patients who've tried at least three classes of antiretroviral drugs, including protease inhibitors and NNRTIs. They must have been on their current PI regimen for 12+ weeks, weigh between 60-100 kg, be over 18 years old with a viral load ≥1000 copies/mL. Pregnant or breastfeeding women, those planning pregnancy or unable to use contraception are excluded.Check my eligibility

What is being tested?

The study tests high doses of lopinavir/ritonavir in capsule or liquid form alongside other anti-HIV meds in patients whose virus hasn't fully responded to previous treatments. It will compare the body's absorption of both drug forms and assess safety and effectiveness.See study design

What are the potential side effects?

Potential side effects include digestive issues like diarrhea (if not already controlled), changes in liver enzymes which may indicate liver problems, increased cholesterol or triglycerides levels, and possible interactions with other medications that affect the cytochrome P450 system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 and living with HIV-1.

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My weight is between 60 and 100 kg.

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I have been treated with three different HIV drug classes, including protease inhibitors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To evaluate the safety and efficacy of high dose kaletra liquid and capsules in the treatment of highly antiretroviral experienced, protease inhibitor resistant HIV disease.

Secondary outcome measures

To compare traditional pharmacokinetic measures of the two formulations (kaletra liquid and kaletra capsules) in a subset of the patients included in the primary analysis.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbottIndustry Sponsor

751 Previous Clinical Trials

478,155 Total Patients Enrolled

Lampiris, Harry W., M.D.Lead Sponsor

Harry W. Lampiris, M.D.Principal InvestigatorSan Francisco Veterans Affairs Medical Center

Media Library

Lopinavir (Protease Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00247143 — N/A

HIV/AIDS Clinical Trial 2023: Lopinavir Highlights & Side Effects. Trial Name: NCT00247143 — N/A

Lopinavir (Protease Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00247143 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to join this research endeavor?

"As indicated on clinicaltrials.gov, this research study is no longer recruiting patients at present. Initially posted in October of 2005 and last edited 18th September 2006, it has since been superseded by 245 other medical trials that are currently accepting participants."

Answered by AI

Is enrollment open to individuals aged seventy-five and over for this experiment?

"As outlined in the study's specifications, participants must be between 18 and 65 years of age to take part."

Answered by AI

Would I be a suitable candidate to join this experiment?

"This experiment is accepting 20 people suffering from AIDS that are older than 18. All participants must have a body mass index (BMI) between 60 kg and 100 kg in order to qualify."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

High Dose Ritonavir/Lopinavir Liquid Formulation in Salvage Therapy for Protease Inhibitor Resistant HIV Disease

2005. "High Dose Ritonavir/Lopinavir Liquid Formulation in Salvage Therapy for Protease Inhibitor Resistant HIV Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00247143.

All > Aids