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Nucleoside Reverse Transcriptase Inhibitor

Combination Antiretroviral Therapy for HIV

Phase 3

Waitlist Available

Research Sponsored by PPD

Eligibility Criteria Checklist

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

Must have

Patients who failed to keep their viral load low during previous anti-HIV treatment

Patients who are at least 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat HIV. It will compare how well the drugs work in men and women.

Who is the study for?

This trial is for HIV-positive adults who've had unsuccessful anti-HIV treatments, with a viral load over 500 copies/ml. They must have used certain anti-HIV drugs for at least 8 weeks and agree to effective birth control use. Excluded are those with certain cancers, medication absorption issues, recent experimental drug use, pregnancy or breastfeeding, active opportunistic infections, peripheral neuropathy risks, pancreatitis risks or specific excluded medications.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of a multi-drug regimen: indinavir plus ritonavir plus enteric-coated didanosine plus stavudine in men and women. It aims to understand gender differences in response to this combination therapy in patients previously treated for HIV.See study design

What are the potential side effects?

Potential side effects may include digestive issues due to enteric-coated didanosine; nerve damage symptoms from stavudine; kidney stones or high blood sugar from indinavir; and increased cholesterol levels or liver toxicity from ritonavir.

Eligibility Criteria

Inclusion Criteria

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

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My previous HIV treatments did not keep my viral load low.

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I am 18 years old or older.

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

PPDLead Sponsor

159 Previous Clinical Trials

36,715 Total Patients Enrolled

Media Library

Enteric-Coated Didanosine (Nucleoside Reverse Transcriptase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00006397 — Phase 3

Human Immunodeficiency Virus Infection Research Study Groups:

Human Immunodeficiency Virus Infection Clinical Trial 2023: Enteric-Coated Didanosine Highlights & Side Effects. Trial Name: NCT00006397 — Phase 3

Enteric-Coated Didanosine (Nucleoside Reverse Transcriptase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00006397 — Phase 3

Frequently Asked Questions

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

Are there multiple hospitals testing this procedure within city limits?

"JSI Research and Training Institute in Boston, Massachusetts, Univ of Texas Southwestern Med Ctr in Dallas, Texas, Beth Israel Med Ctr in New york, New York are a few of the medical centres where this trial is taking place. There are a total of 13 sites across America."

Answered by AI

Has this particular medicine been federally sanctioned?

"This treatment received a score of 3 for safety because it is in Phase 3 clinical trials. This signifies that, while there is data supporting efficacy, multiple rounds of data are available to support the safety of this medication."

Answered by AI

does this research include participants who are 18 years old or older?

"In order to meet the requirements for this specific clinical trial, applicants must be between 18 and 0 years old. Out of the 110 total clinical trials, there are only 367 that involve patients over 65."

Answered by AI

Who meets the screening criteria for participation in this experiment?

"To qualify for this trial, participants must be HIV positive, between the ages of 18 and 0, and have a history of treatment with NNRTIs plus an NRTI combination or only NRTIs for more than 8 weeks. Additionally, if not currently on treatment, individuals cannot have been off treatment for more than 12 weeks. Finally, all potential candidates must have failed to keep their viral load low during previous anti-HIV treatment attempts."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Differences Between Women and Men Taking a Combination of Indinavir, Ritonavir, Enteric-Coated Didanosine, and Stavudine Who Previously Took Anti-HIV Drugs

2000. "Differences Between Women and Men Taking a Combination of Indinavir, Ritonavir, Enteric-Coated Didanosine, and Stavudine Who Previously Took Anti-HIV Drugs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00006397.

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