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

NCT ID: NCT00002224

Last Updated: 2011-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-03-31

Study Completion Date

1999-03-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Nelfinavir mesylate

Intervention Type DRUG

Stavudine

Intervention Type DRUG

Didanosine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Locations

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Sorra Research Ctr / Med Forum

Birmingham, Alabama, United States

Site Status

AIDS Healthcare Foundation

Los Angeles, California, United States

Site Status

Robert Scott MD

Oakland, California, United States

Site Status

Beacon Clinic / Boulder Community Hosp

Boulder, Colorado, United States

Site Status

Community Health Care

Fort Lauderdale, Florida, United States

Site Status

Immunity Care and Research Inc

Fort Lauderdale, Florida, United States

Site Status

HIV Clinical Research Ctr

Fort Lauderdale, Florida, United States

Site Status

South Shore Hosp

Miami, Florida, United States

Site Status

Saint Josephs Comprehensive Research Institute

Tampa, Florida, United States

Site Status

AIDS Research Consortium of Atlanta

Atlanta, Georgia, United States

Site Status

Chicago Ctr for Clinical Research

Chicago, Illinois, United States

Site Status

Univ of Kansas School of Medicine

Wichita, Kansas, United States

Site Status

Univ of Nebraska Med Ctr

Omaha, Nebraska, United States

Site Status

Clinical Studies of Las Vegas

Las Vegas, Nevada, United States

Site Status

Anderson Clinical Research Inc

Rego Park, New York, United States

Site Status

Anderson Clinical Research Inc

Reading, Pennsylvania, United States

Site Status

Coastal Carolina Research Ctr

Mt. Pleasant, South Carolina, United States

Site Status

Oak Lawn Physicians Group

Dallas, Texas, United States

Site Status

Univ of Texas Southwestern Med Ctr of Dallas

Dallas, Texas, United States

Site Status

Nicholaos Bellos

Dallas, Texas, United States

Site Status

Houston Clinical Research Network / Div of Montrose Clinic

Houston, Texas, United States

Site Status

Swedish Med Ctr

Seattle, Washington, United States

Site Status

Clinique Medicale du Quartier Latin

Montreal, Quebec, Canada

Site Status

Clinique Medicale L'Actuele

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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AI454-158

Identifier Type: -

Identifier Source: secondary_id

039G

Identifier Type: -

Identifier Source: org_study_id

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