Comparison of Two Anti-HIV Regimens That Include One of Two Forms of Didanosine (ddI)

Condition(s) targeted: HIV Infections

Intervention: Nelfinavir mesylate (Drug); Stavudine (Drug); Didanosine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
. ., Principal Investigator, Affiliation: .

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).

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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Sorra Research Ctr / Med Forum, Birmingham, Alabama 35203, United States

Robert Scott MD, Oakland, California 94609, United States

AIDS Healthcare Foundation, Los Angeles, California 900276069, United States

Beacon Clinic / Boulder Community Hosp, Boulder, Colorado 80304, United States

HIV Clinical Research Ctr, Fort Lauderdale, Florida 33316, United States

Saint Josephs Comprehensive Research Institute, Tampa, Florida 33607, United States

Community Health Care, Fort Lauderdale, Florida 33306, United States

Immunity Care and Research Inc, Fort Lauderdale, Florida 33311, United States

South Shore Hosp, Miami, Florida 33139, United States

AIDS Research Consortium of Atlanta, Atlanta, Georgia 303081962, United States

Chicago Ctr for Clinical Research, Chicago, Illinois 60610, United States

Univ of Kansas School of Medicine, Wichita, Kansas 672143124, United States

Univ of Nebraska Med Ctr, Omaha, Nebraska 681985400, United States

Clinical Studies of Las Vegas, Las Vegas, Nevada 89128, United States

Anderson Clinical Research Inc, Rego Park, New York 11374, United States

Anderson Clinical Research Inc, Reading, Pennsylvania 19604, United States

Clinique Medicale L'Actuele, Montreal, Quebec, Canada

Clinique Medicale du Quartier Latin, Montreal, Quebec, Canada

Coastal Carolina Research Ctr, Mount Pleasant, South Carolina 29464, United States

Oak Lawn Physicians Group, Dallas, Texas 75219, United States

Nicholaos Bellos, Dallas, Texas 75246, United States

Univ of Texas Southwestern Med Ctr of Dallas, Dallas, Texas 752359103, United States

Houston Clinical Research Network / Div of Montrose Clinic, Houston, Texas 77006, United States

Swedish Med Ctr, Seattle, Washington 98122, United States

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: March 1999
Ending date: March 1999
Last updated: August 15, 2007