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Nucleoside Reverse Transcriptase Inhibitor

Emtricitabine/Stavudine + Didanosine/Efavirenz for HIV Infection

Phase 3
Waitlist Available
Research Sponsored by Triangle Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be at least 18 years old at the time of screening
Patients must not have used any anti-HIV therapy for more than 2 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial will compare the safety and effectiveness of three different HIV medications.

Who is the study for?
This trial is for adults over 18 with HIV who haven't taken anti-HIV drugs for more than 2 days and have high levels of HIV in their blood. They must not be on certain medications, have serious mental disorders or neuropathy, use heavy alcohol or illegal drugs, or have severe chronic digestive issues. Pregnant/breastfeeding individuals and those unwilling to use birth control are excluded.Check my eligibility
What is being tested?
The study compares the safety and effectiveness of two drug combinations against HIV: one includes emtricitabine with didanosine plus efavirenz; the other uses stavudine instead of emtricitabine with the same additional drugs.See study design
What are the potential side effects?
Potential side effects may include nausea, vomiting, diarrhea, headaches, dizziness, rash, changes in body fat distribution (lipodystrophy), liver problems like hepatitis B reactivation if co-infected. Specific side effects can vary based on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have not used HIV medication for more than 2 days.

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?

Triangle PharmaceuticalsLead Sponsor
11 Previous Clinical Trials
959 Total Patients Enrolled

Media Library

Didanosine (Nucleoside Reverse Transcriptase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00006208 — Phase 3
Human Immunodeficiency Virus Infection Research Study Groups:
Human Immunodeficiency Virus Infection Clinical Trial 2023: Didanosine Highlights & Side Effects. Trial Name: NCT00006208 — Phase 3
Didanosine (Nucleoside Reverse Transcriptase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00006208 — Phase 3

Frequently Asked Questions

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

Could you explain the age restrictions for this research project?

"The age requirement to enroll in this trial is 18 to 0 years old. There are a total of 109 studies for patients under 18 and 364 for those over 65."

Answered by AI

How many staff members are needed to manage this clinical trial at each location?

"This trial has a presence in George Washington Univ Med Ctr in Washington, District of Columbia, Howard Grossman in New york, New York, Viridae Clinical Sciences / University of British Columbia in Vancouver, British Columbia, and 55 other medical centres."

Answered by AI

Are there any patients currently enrolled in this research?

"No, the clinical trial is not recruiting patients at the moment. The clinical trial was originally posted on 8/1/2000 and was last updated on 6/23/2005. There are 495 other studies presently searching for participants right now."

Answered by AI

What side effects should patients be made aware of before starting this medication regimen?

"This trial is a Phase 3, which suggests that while there is data affirming the treatment's efficacy, there are also multiple rounds of data supporting safety. Therefore, the safety of the treatment was rated a 3."

Answered by AI

Who else is applying?

What state do they live in?
Louisiana
Texas
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
0
What site did they apply to?
Davies Med Ctr
Houston Clinical Research Network

Why did patients apply to this trial?

~14 spots leftby Mar 2025