Completed

Comparison of HIV RNA Suppression Produced by Triple Regimens Containing Either Didanosine Enteric Coated or Didanosine Formulations Each Administered Once Daily

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Nelfinavir mesylate

+ Stavudine

+ Didanosine

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: March 1999
See protocol details

Summary

Principal SponsorBristol-Myers Squibb
Last updated: April 25, 2011
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 1999

Actual date on which the first participant was enrolled.

Patients are randomized to 1 of 2 open-label treatment groups. Group 1 receives ddI EC plus d4T plus NLF for 48 weeks. Group 2 receives ddI plus d4T plus NLF for 48 weeks. Both forms of ddI are administered orally once daily. Antiviral activity is determined by the magnitude and the duration of reduction of plasma HIV RNA from baseline through Week 24.

NCT00002224
Principal SponsorBristol-Myers Squibb
Last updated: April 25, 2011
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections

Criteria

Inclusion Criteria You may be eligible for this study if you: Are HIV-positive. Are at least 18 years old. Have a viral load of at least 5,000 copies/ml and a CD4 count of at least 100 cells/mm3. Exclusion Criteria You will not be eligible for this study if you: Have received more than 4 weeks of treatment with nucleoside anti-HIV medications (NRTIs), or more than 1 week with protease inhibitors. (All anti-HIV treatments other than study medications must be stopped at least 14 days prior to study entry.) Have severe diarrhea. Are pregnant or breast-feeding. Have a history of pancreatic disease or any other serious condition. Have hepatitis within 30 days prior to study entry. Cannot take medications by mouth. Have received certain medications.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 24 locations

Sorra Research Ctr / Med Forum

Birmingham, United StatesOpen Sorra Research Ctr / Med Forum in Google Maps

AIDS Healthcare Foundation

Los Angeles, United States

Robert Scott MD

Oakland, United States

Beacon Clinic / Boulder Community Hosp

Boulder, United States
Completed24 Study Centers