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Protease Inhibitor

Antiretroviral Therapy for HIV

Phase 2
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have had an initial response to protease inhibitor therapy with a viral load of less than 400 copies/ml in two consecutive tests at least 1 week apart
Patients must have had virologic failure (two consecutive viral loads that were greater than or equal to 400 copies/ml and less than or equal to 20,000 copies/ml at least 1 week apart) that is not due to another infection, vaccination, or a temporary stop in treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a new HIV treatment regimen.

Who is the study for?
This trial is for HIV-positive adults over 18 who have been on antiretroviral treatment including indinavir or nelfinavir for at least 16 weeks and are experiencing virologic failure. They must have a CD4 cell count of at least 50 cells/mm3, and their viral load should be between 400 to 20,000 copies/ml.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of combining indinavir with ritonavir plus two NRTIs (nucleoside reverse transcriptase inhibitors) in patients needing early intervention for HIV.See study design
What are the potential side effects?
Potential side effects may include gastrointestinal issues like nausea and diarrhea, liver problems, changes in body fat distribution, increased cholesterol levels, possible resistance to medication if not taken as prescribed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My HIV treatment initially worked, lowering my viral load below 400 in two tests.
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My HIV treatment failed twice with viral loads between 400 and 20,000.
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I have not used at least one of the specific HIV medications before.
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I am 18 years old or older.
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I have been on HIV treatment including indinavir or nelfinavir for at least 16 weeks.

Timeline

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

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,811 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,862 Previous Clinical Trials
5,049,600 Total Patients Enrolled

Media Library

Indinavir (Protease Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00005118 — Phase 2
Human Immunodeficiency Virus Infection Research Study Groups:
Human Immunodeficiency Virus Infection Clinical Trial 2023: Indinavir Highlights & Side Effects. Trial Name: NCT00005118 — Phase 2
Indinavir (Protease Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00005118 — Phase 2

Frequently Asked Questions

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

At how many different hospitals is this clinical trial being conducted?

"There are 40 clinical trial sites for this medication, which can be found in locations such as Stony Brook, Los Angeles and Mt. Vernon among other places. To limit travel if you enroll, it is best to choose the location nearest you."

Answered by AI

Is this clinical trial only testing on individuals below a certain age?

"In order to be eligible for this study, potential participants must between 18 and 0 years old. There are currently 110 trials for people under the age of 18 and 367 for those over 65."

Answered by AI

Has this particular medication been cleared by the FDA?

"While there is some evidence of this treatment's safety, it remains unproven whether or not it is effective. Our team rates its safety as a 2."

Answered by AI

Does this clinical trial have any prerequisites for participants?

"100 individuals infected with HIV that meet the following conditions are eligible for this study: being 18 years or older, having used antiretroviral treatment including indinavir or nelfinavir for a minimum of 16 weeks, and being unexposed to one of the selected NRTIs."

Answered by AI

Who else is applying?

What site did they apply to?
Mt Vernon Hosp
Wake Forest Univ School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

And looking for something that will help me live even longer than I have been living ain't no things are happening to my voice to HIV I am looking for an even stronger medicine that I can take, and it's not for myself I can help anyone else that's infected with this virus.
PatientReceived 1 prior treatment
~67 spots leftby Mar 2025