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Protease Inhibitor

GW433908 vs Nelfinavir for HIV

Phase 3
Waitlist Available
Research Sponsored by Glaxo Wellcome
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Are at least 13 years old (consent of parent or guardian required if under 18).
Have received less than 4 weeks treatment with any nucleoside reverse transcriptase inhibitor (NRTI) and have never received any nonnucleoside reverse transcriptase inhibitor (NNRT) or protease inhibitor (PI).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial will compare the effectiveness of two HIV drugs, GW433908 and nelfinavir, when each is given with abacavir and lamivudine to patients who have not previously taken antiretroviral drugs.

Who is the study for?
This trial is for HIV patients aged 13 or older who haven't had antiretroviral therapy, except possibly less than 4 weeks of NRTI treatment. They must have a viral load over 5,000 copies/ml and agree to use barrier contraception. It's not for those with serious conditions like heart disease or diabetes, pregnant or breastfeeding women, recent chemotherapy/radiation recipients, immune system drug users within the last month, or those with substance abuse issues.Check my eligibility
What is being tested?
The study compares two drugs: GW433908 and nelfinavir when taken alongside abacavir and lamivudine in HIV patients without prior antiretroviral treatment. The goal is to see which combination works better at controlling the virus.See study design
What are the potential side effects?
Potential side effects may include digestive problems (nausea, diarrhea), allergic reactions, changes in body fat distribution and blood sugar levels (for diabetic patients), liver problems like hepatitis, skin rash and increased risk of infection due to weakened immunity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am at least 13 years old and have consent if under 18.
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I have taken NRTI drugs for less than 4 weeks and never taken NNRT or PI drugs.
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I might qualify for this study.

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

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Who is running the clinical trial?

Glaxo WellcomeLead Sponsor
120 Previous Clinical Trials
24,220 Total Patients Enrolled

Media Library

GW433908 (Protease Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00008554 — Phase 3
Human Immunodeficiency Virus Infection Research Study Groups:
Human Immunodeficiency Virus Infection Clinical Trial 2023: GW433908 Highlights & Side Effects. Trial Name: NCT00008554 — Phase 3
GW433908 (Protease Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00008554 — Phase 3

Frequently Asked Questions

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

Does this research allow for senior citizens to participate?

"According to the age requirements specified in this trial's inclusion criteria, the minimum age for participation is 13 and the maximum age is 0."

Answered by AI

Are there any current openings for individuals in this research project?

"Unfortunately, this particular clinical trial is no longer recruiting patients, as noted on clinicaltrials.gov. This study was first posted on November 1st, 2000 but was last edited on June 23rd, 2005. Although this study is not taking any more participants, there are 495 other trials that are currently looking for patients."

Answered by AI

Has this medication been federally approved in the United States?

"There is some evidence of this treatment's efficacy and it has undergone multiple rounds of testing, so Power rates its safety as a 3."

Answered by AI

Are there any specific requirements for this trial's participants?

"The purpose of this study is to enroll 210 HIV positive individuals that are 13 years or older. In order to be eligible, potential participants must agree to use an effective method of birth control (such as spermicide in conjunction with a condom) during the study period, if they are of childbearing age. Additionally, applicants that have received nucleoside reverse transcriptase inhibitor treatment for less than 4 weeks, and have never received nonnucleoside reverse transcriptase inhibitor or protease inhibitor treatment in the past, are welcome to apply."

Answered by AI
~9 spots leftby Mar 2025