Multicentric Trial Comparing Three Therapeutical Strategies in Patients With Acute Primary HIV Infection

HIV Infections Clinical Trial

Official title:

Multicentric Trial Comparing Three Therapeutical Strategies in Patients With Acute Primary HIV Infection.ANRS 112 INTERPRIM

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00196638
• Other study ID #: ANRS 112 INTERPRIM
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: September 12, 2005
• Last updated: August 28, 2006
• Start date: May 2002
• Est. completion date: March 2006

Study information

• Verified date: August 2006
• Source: French National Agency for Research on AIDS and Viral Hepatitis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Treatment of acute primary HIV infection may improve long-term outcome. However, optimal treatment is still debated. The ANRS 112-INTERPRIM trial evaluates three different therapeutical strategies, combining permanent or intermittent HAART and a cytokine, interferon alpha, in order to determine which combination allows the best control of HIV viremia after 24 weeks of antiretroviral treatment interruption

Description:

Treatment of acute primary HIV infection may improve long-term outcome. However, optimal treatment is still debated. The main objective of this multicentric randomized phase II/III study is to compare HIV viremia 92 and 96 weeks after acute primary HIV infection, between patients treated with 3 different strategies. In the first group, patients receive antiretroviral drugs (HAART) continuously up to week 72. In the second group, patients receive HAART continuously up to week 36, then intermittently up to week 72. In the third group, patients receive HAART as in group II, and pegylated interferon alpha is administered for the initial 14 weeks, then for 3 weeks at each of the 3 HAART interruption between week 36 and week 72. All patients are monitored without any HAART up to week 96. Enrolled patients have circulating p24 antigen and/or HIV viremia, an uncompleted HIV western blot, between 18 and 65 years old, and agree to participate to the study. They should have received no antiretroviral drugs, not be pregnant, without neuro-psychological or autoimmune disorders, without chronic hepatitis. Secondary objectives of the study are: the quality of immune restoration, the anti-HIV immune response, safety and adhesion to treatment. A total of 90 patients (30 in each group) have been enrolled.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• P24 antigen with positive neutralization or positive plasma HIV RNA

• Negative or not complete Western Blot

• With symptoms or not

• Written informed consent

Exclusion Criteria:

• Previous antiretroviral treatment

• Pregnancy

• Biological abnormalities

• Hepatitis C or B

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• Infection
• Primary Acute Infection

Intervention

Drug:
• Antiretroviral combination (drugs)

• Pegylated Interferon alpha (drug)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis	Hoffmann-La Roche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma HIV RNA at Week 92 and 96 (mean)
Secondary	Plasma HIV RNA kinetics after treatment interruption
Secondary	CD4 cell count
Secondary	Proviral DNA
Secondary	Adherence