Clinical trial NCT00002429: Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen
Official title: Evaluation of HIV RNA Suppression Produced by a Triple Combination Regimen Containing an Enteric Coated Formulation of Didanosine (ddI EC) Administered Once Daily Compared to a Reference Combination Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Didanosine
Drug Therapy, Combination
Stavudine
RNA, Viral
Nelfinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study tests a new form of didanosine, ddI EC, a coated pill that passes through the stomach before dissolving. The purpose of this study is to compare the effectiveness of an anti-HIV drug combination that includes ddI EC versus another anti-HIV drug combination.

Detailed description: Patients are randomized to 1 of 2 groups for 48 weeks of open-label treatment. Group 1 receives ddI EC plus d4T plus NFV. Group 2 receives Combivir plus NFV. Antiviral activity is determined by the proportion of patients with HIV RNA levels of less than 400 copies/ml at Week 48.

Eligibility criteria: Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Have a viral load of at least 2,000 copies/ml and a CD4 count of at least 200 cells/mm3.
* Are at least 18 years old.
* Agree to practice sexual abstinence or to use effective barrier methods of birth control (such as condoms).

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have had severe diarrhea within 30 days of study entry.
* Have a history of pancreatic disease or any other serious condition.
* Have hepatitis within 30 days of study entry.
* Are diagnosed with an opportunistic (AIDS-related) infection at the time of enrollment.
* Are unable to take medications by mouth.
* Have received certain medications.
* Are pregnant or breast-feeding.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sorra Research Ctr / Med Forum
state: Alabama
city: Phoenix
country: United States
facility: Body Positive
state: Arizona
city: Los Angeles
country: United States
facility: AIDS Healthcare Foundation
state: California
city: San Francisco
country: United States
facility: San Francisco Gen Hosp
state: California
city: Fort Lauderdale
country: United States
facility: Med Alternatives
state: Florida
city: Pembrook
country: United States
facility: County Line Med CtrInc
state: Florida
city: Vero Beach
country: United States
facility: Dr Gerald Pierone Jr
state: Florida
city: Chicago
country: United States
facility: The CORE Ctr
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Univ Med Ctr
state: Indiana
city: Wichita
country: United States
facility: Univ of Kansas School of Medicine
state: Kansas
city: Detroit
country: United States
facility: Henry Ford Hosp
state: Michigan
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Med Ctr
state: New Hampshire
city: Newark
country: United States
facility: NJCRI
state: New Jersey
city: Somerville
country: United States
facility: Infectious Disease Assoc of Central Jersey
state: New Jersey
city: Columbus
country: United States
facility: Ohio State Univ Hosp Clinic
state: Ohio
city: Pittsburgh
country: United States
facility: Anderson Clinical Research
state: Pennsylvania
city: Dallas
country: United States
facility: Univ of Texas Southwestern Med Ctr of Dallas
state: Texas
city: Houston
country: United States
facility: Gathe, Joseph, M.D.
state: Texas
city: Houston
country: United States
facility: Montrose Clinic
state: Texas
city: Hampton
country: United States
facility: Hampton Roads Med Specialists
state: Virginia
city: Montreal
country: Canada
facility: Clinique Medicale du Quartier Latin
state: Quebec
city: Montreal
country: Canada
facility: Clinique Medicale L'Actuele
state: Quebec
city: Montreal
country: Canada
facility: Dr Roger P Leblanc
state: Quebec
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Gathe J, Badero R, Grimwood A, Abrams L, Klesczewski K, Mclaren C. AI454152: Comparison of a Triple Combination Regimen Containing an Enteric Coated Formulation of Didanosine Administered Once-Daily Versus a Regimen of Combivir Plus Nelfinavir. 8th Conference on Retroviruses and Opportunistic Infections, 2001 Feb 4-8. (abstract no 319)