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Completed

NCT Number: 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

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinique Medicale L'Actuele, Montreal, Quebec, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lamivudine/Zidovudine

Drug

nelfinavir mesylate

Drug

Stavudine

Drug

Didanosine

Drug

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
1999
Primary completion
2001
Study completion
2001
First posted
Aug 31, 2001
Registry last updated
May 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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