Clinical trial NCT00002224: Comparison of Two Anti-HIV Regimens That Include One of Two Forms of Didanosine (ddI)
Official title: Comparison of HIV RNA Suppression Produced by Triple Regimens Containing Either Didanosine Enteric Coated or Didanosine Formulations Each Administered Once Daily
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Didanosine
Drug Therapy, Combination
Drug Administration Schedule
Stavudine
HIV Protease Inhibitors
Nelfinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: 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.

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sorra Research Ctr / Med Forum
state: Alabama
city: Los Angeles
country: United States
facility: AIDS Healthcare Foundation
state: California
city: Oakland
country: United States
facility: Robert Scott MD
state: California
city: Boulder
country: United States
facility: Beacon Clinic / Boulder Community Hosp
state: Colorado
city: Fort Lauderdale
country: United States
facility: Community Health Care
state: Florida
city: Fort Lauderdale
country: United States
facility: Immunity Care and Research Inc
state: Florida
city: Fort Lauderdale
country: United States
facility: HIV Clinical Research Ctr
state: Florida
city: Miami
country: United States
facility: South Shore Hosp
state: Florida
city: Tampa
country: United States
facility: Saint Josephs Comprehensive Research Institute
state: Florida
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Chicago Ctr for Clinical Research
state: Illinois
city: Wichita
country: United States
facility: Univ of Kansas School of Medicine
state: Kansas
city: Omaha
country: United States
facility: Univ of Nebraska Med Ctr
state: Nebraska
city: Las Vegas
country: United States
facility: Clinical Studies of Las Vegas
state: Nevada
city: Rego Park
country: United States
facility: Anderson Clinical Research Inc
state: New York
city: Reading
country: United States
facility: Anderson Clinical Research Inc
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Ctr
state: South Carolina
city: Dallas
country: United States
facility: Oak Lawn Physicians Group
state: Texas
city: Dallas
country: United States
facility: Univ of Texas Southwestern Med Ctr of Dallas
state: Texas
city: Dallas
country: United States
facility: Nicholaos Bellos
state: Texas
city: Houston
country: United States
facility: Houston Clinical Research Network / Div of Montrose Clinic
state: Texas
city: Seattle
country: United States
facility: Swedish Med Ctr
state: Washington
city: Montreal
country: Canada
facility: Clinique Medicale du Quartier Latin
state: Quebec
city: Montreal
country: Canada
facility: Clinique Medicale L'Actuele
state: Quebec
Study officials:
References: