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

Primary Purpose

HIV Infections, Antiretroviral Naive

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

emtricitabine, FTC (drug)

didanosine, ddI (drug)

efavirenz (drug)

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV infections, Reverse Transcriptase Inhibitors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Virological success

Secondary Outcome Measures

Treatment adherence

CD4 cell count

Safety

Progression of HIV infection

Pharmacokinetics criteria

Full Information

NCT ID

NCT00196599

First Posted

September 12, 2005

Last Updated

September 12, 2005

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00196599

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Completed

Study Start Date

February 1999 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Collaborators

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

4. Oversight

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections, Antiretroviral Naive

Keywords

HIV infections, Reverse Transcriptase Inhibitors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

39 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

emtricitabine, FTC (drug)

Intervention Type

Drug

Intervention Name(s)

didanosine, ddI (drug)

Intervention Type

Drug

Intervention Name(s)

efavirenz (drug)

Primary Outcome Measure Information:

Title

Virological success

Secondary Outcome Measure Information:

Title

Treatment adherence

Title

CD4 cell count

Title

Safety

Title

Progression of HIV infection

Title

Pharmacokinetics criteria

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Michel Molina, MD, PhD

Organizational Affiliation

Service de Maladies Infectieuses, Hôpital Saint-Louis, Paris, 75475, France

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Genevieve Chene, MD, PhD

Organizational Affiliation

INSERM unité 593, Bordeaux, France

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

10915095

Citation

Molina JM, Ferchal F, Rancinan C, Raffi F, Rozenbaum W, Sereni D, Morlat P, Journot V, Decazes JM, Chene G. Once-daily combination therapy with emtricitabine, didanosine, and efavirenz in human immunodeficiency virus-infected patients. J Infect Dis. 2000 Aug;182(2):599-602. doi: 10.1086/315711. Epub 2000 Jul 13.

Results Reference

result

PubMed Identifier

15012649

Citation

Molina JM, Peytavin G, Perusat S, Lascoux-Combes C, Sereni D, Rozenbaum W, Chene G. Pharmacokinetics of emtricitabine, didanosine and efavirenz administered once-daily for the treatment of HIV-infected adults (pharmacokinetic substudy of the ANRS 091 trial). HIV Med. 2004 Mar;5(2):99-104. doi: 10.1111/j.1468-1293.2004.00194.x.

Results Reference

result

Learn more about this trial

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

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