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Clinical Trials

MainTitle

Pilot Study on Once Daily FTC, ddI, Efavirenz Combination in Antiretroviral Naive HIV Infected Adults

This study has been completed
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis

Collaborator
Triangle Pharmaceuticals
Gilead Sciences
Bristol-Myers Squibb
Dupont Applied Biosciences

Information provided by (Responsible Party)
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier
NCT00196599

First received: September 12, 2005
Last updated: September 12, 2005
Last Verified: September 2005
History of Changes
Purpose

Purpose

In 1999, when initiating antiretroviral treatment in HIV infected adults, a triple combination with protease inhibitor is recommended. Such therapy induces side effects and the number of pills may reduce therapy adherence. The aim of this study is to evaluate the efficacy and the safety of a once daily FTC, ddI, efavirenz combination, in HIV patients with CD4 cell count over 100/mm3, antiretroviral naive.

Condition Intervention Phase
HIV Infections
Antiretroviral Naive

Drug : emtricitabine, FTC (drug)
Drug : didanosine, ddI (drug)
Drug : efavirenz (drug)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study on Efficacy and Safety of a Once Daily FTC, ddI, Efavirenz Combination in Antiretroviral Naive HIV Infected Adults. ANRS 091 MONTANA

Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures

  • Virological success
Secondary Outcome Measures:
  • Treatment adherence
  • CD4 cell count
  • Safety
  • Progression of HIV infection
  • Pharmacokinetics criteria

Enrollment: 39
Study Start Date: February 1999
Study Completion Date: September 2004

Detailed Description:

In 1999, when initiating antiretroviral treatment in HIV infected adults, a triple combination with protease inhibitor is recommended. Side effects of this products and the number of pills may induce a lower adherence, and thus a lower efficacy. 40 patients with a CD4 count over 100/mm3, a HIV RNA over 5,000 copies/ml and antiretroviral naive, take the once daily combination of FTC, ddI, efavirenz during 24 weeks. The primary end-point is the viral success maintained from 12 weeks until 24 weeks. Secondary end-point is the adherence to the association and safety.
The trial is prolonged during a total of 72 weeks.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  • HIV infection
  • Antiretroviral naive
  • CD4 cell count over 100/mm3
  • Plasma HIV RNA load over 5,000 copies/mL
    • Signed written informed consent


    Exclusion Criteria:
  • Hepatitis B infection
  • Pregnancy
  • Alcool abuse
  • Acute infection, past neurological or pancreatic disease, biological abnormalities
  • Chemotherapy or immunotherapy

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196599

Sponsors and Collaborators

French National Agency for Research on AIDS and Viral Hepatitis
Triangle Pharmaceuticals
Gilead Sciences
Bristol-Myers Squibb
Dupont Applied Biosciences

Investigators

Principal Investigator: Jean-Michel Molina, MD, PhD Service de Maladies Infectieuses, Hôpital Saint-Louis, Paris, 75475, France
Study Director: Genevieve Chene, MD, PhD INSERM unité 593, Bordeaux, France
More Information

More Information


Responsible Party: French National Agency for Research on AIDS and Viral Hepatitis  
ClinicalTrials.gov Identifier: NCT00196599   History of Changes  
Other Study ID Numbers: ANRS 091 MONTANA  
Study First Received: September 12, 2005  
Last Updated: September 12, 2005  

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:

HIV infections
Reverse Transcriptase Inhibitors

Additional relevant MeSH terms:
HIV Infections
Emtricitabine
Efavirenz
Didanosine

ClinicalTrials.gov processed this data on October 23, 2017
This information is provided by ClinicalTrials.gov.