NCT00002224

Brief Summary

Didanosine is an effective anti-HIV drug, but it can cause stomach upset. This study tests a new form of didanosine, ddI EC, a coated pill that passes through the stomach more easily and hopefully will prevent stomach upset. The purpose of this study is to compare the effectiveness of ddI EC versus the standard form of ddI. Both forms of ddI will be given with stavudine (d4T) plus nelfinavir (NLF).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at below P25 for phase_3 hiv-infections

Timeline
Completed

Started Mar 1999

Geographic Reach
2 countries

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1999

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 1999

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 1999

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

April 25, 2011

Status Verified

April 1, 2011

Enrollment Period

Same day

First QC Date

November 2, 1999

Last Update Submit

April 13, 2011

Conditions

HIV Infections

Keywords

DidanosineDrug Therapy, CombinationDrug Administration ScheduleStavudineHIV Protease InhibitorsNelfinavirReverse Transcriptase InhibitorsAnti-HIV AgentsViral Load

Interventions

Nelfinavir mesylateDRUG
StavudineDRUG
DidanosineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Sorra Research Ctr / Med Forum

Birmingham, Alabama, 35203, United States

Location

AIDS Healthcare Foundation

Los Angeles, California, 900276069, United States

Location

Robert Scott MD

Oakland, California, 94609, United States

Location

Beacon Clinic / Boulder Community Hosp

Boulder, Colorado, 80304, United States

Location

Community Health Care

Fort Lauderdale, Florida, 33306, United States

Location

Immunity Care and Research Inc

Fort Lauderdale, Florida, 33311, United States

Location

HIV Clinical Research Ctr

Fort Lauderdale, Florida, 33316, United States

Location

South Shore Hosp

Miami, Florida, 33139, United States

Location

Saint Josephs Comprehensive Research Institute

Tampa, Florida, 33607, United States

Location

AIDS Research Consortium of Atlanta

Atlanta, Georgia, 303081962, United States

Location

Chicago Ctr for Clinical Research

Chicago, Illinois, 60610, United States

Location

Univ of Kansas School of Medicine

Wichita, Kansas, 672143124, United States

Location

Univ of Nebraska Med Ctr

Omaha, Nebraska, 681985400, United States

Location

Clinical Studies of Las Vegas

Las Vegas, Nevada, 89128, United States

Location

Anderson Clinical Research Inc

Rego Park, New York, 11374, United States

Location

Anderson Clinical Research Inc

Reading, Pennsylvania, 19604, United States

Location

Coastal Carolina Research Ctr

Mt. Pleasant, South Carolina, 29464, United States

Location

Oak Lawn Physicians Group

Dallas, Texas, 75219, United States

Location

Univ of Texas Southwestern Med Ctr of Dallas

Dallas, Texas, 752359103, United States

Location

Nicholaos Bellos

Dallas, Texas, 75246, United States

Location

Houston Clinical Research Network / Div of Montrose Clinic

Houston, Texas, 77006, United States

Location

Swedish Med Ctr

Seattle, Washington, 98122, United States

Location

Clinique Medicale du Quartier Latin

Montreal, Quebec, Canada

Location

Clinique Medicale L'Actuele

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

HIV Infections

Interventions

NelfinavirStavudineDidanosine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

IsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesInosinePurine NucleosidesPurinesRibonucleosides

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Start

March 1, 1999

Primary Completion

March 1, 1999

Study Completion

March 1, 1999

Last Updated

April 25, 2011

Record last verified: 2011-04

Locations

CA(2)US(22)