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OpenTrials
Completed

NCT Number: NCT00116415

DART I - A Phase IV Study of 3 Antiretroviral Medicines in Combination, in HIV Patients Who Have Not Been Previously Treated With Antiretroviral Therapy

The purpose of this study is to evaluate whether a therapy with an all once daily regimen of efavirenz (EFV), didanosine (ddI)-EC and lamivudine (3TC) leads to improved outcomes, as measured by viral load, CD4 counts, adherence, safety, and tolerability.

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Key information

Conditions

HIV Infections AIDS Acquired Immunodeficiency Syndrome 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 Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Local Institution, Washington D.C., District of Columbia, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients 18 years of age or older infected with HIV and weigh at least 40 kg.
  • Plasma HIV RNA viral load of 1000 copies/mL or greater and CD4 count of 100 cells/mL or greater
  • Be willing to use two forms of contraception throughout study
  • No previous exposure to antiretroviral (ARV) drugs

Exclusion criteria

  • Pregnancy or breastfeeding
  • Physical or psychiatric disability
  • Proven or suspected acute hepatitis within 30 days prior to study entry
  • Active AIDS-defining opportunistic infection or disease
  • History of acute or chronic pancreatitis

Treatment and study plan

efavirenz; didanosine EC; lamivudine

Drug

Primary outcomes

  1. Estimate efficacy of ddI-EC/3TC/EFV given QD determined by proportion of patients with plasma HIV-1 RNA <400 copies/mL at 48 weeks

Secondary outcomes

  1. Evaluate proportion of patients with plasma HIV RNA <400 copies/mL at Weeks 24, 48, 72, and 96.

  2. Evaluate proportion of patients with plasma HIV RNA <50 copies/mL at Weeks 24, 48, 72, and 96

  3. Determine viral suppression of plasma HIV RNA from change in baseline at week 48

  4. Determine proportion of patients whose HIV viral load doesn't drop to undetectable level within 24 weeks

  5. Evaluate time to undetectable plasma HIV RNA

  6. Evaluate proportion of patients demonstrating virologic breakthrough

  7. Evaluate proportion of patients demonstrating virologic failure

  8. Evaluate time to virologic breakthrough and virologic failure

  9. Measure magnitude and durability of changes in CD4 cell counts

  10. Evaluate patient adherence with QD regimen using pill counts and AMAF

  11. Determine pattern and emergence of HIV genotype resistance mutations in patients experiencing virologic failure

  12. Explore QoL changes using MOS-HIV health survey

  13. Evaluate safety and tolerability of QD regimen

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Daily Antiretroviral Therapy (DART 1): An Open-Label, Single-Arm, Prospective, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Didanosine Enteric Coated (Ddl-EC) in Combination With Lamivudine (3TC) and Efavirenz (EFV) Once Daily in Anti-Retroviral Therapy (ART) Naive HIV-Infected Patients

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Jun 30, 2005
Registry last updated
Apr 22, 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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