A phase IIIb/IV randomised, controlled study evaluating an intensification treatment strategy of adding enfuvirtide (ENF) to an oral Highly Active AntiRetroviral Therapy (HAART) in treatment experienced patients. - INTENSE Study

• Conditions: HIV Infection; Classification code 10020161

• Registration Number: EUCTR2004-004358-24-DE
• Lead Sponsor: F. Hoffmann-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-30
• Last Update Posted: 29 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. HIV-1 infected adults ( > 18 years of age) previously treated with 2 or 3 different ARV classes with a CD4 lymphocyte count =200 cells/mm3 and HIV-1 RNA = 1,000 copies/mL, while on their current pre-study”ARV regimen

2. Must currently be on ARV therapy, with no changes to that regimen for > 4 weeks prior to entering screening (patients on treatment interruption excluded). Patients must remain on their pre-study”regimen unchanged except for toxicity management until BL1

3. Must be able to create a study HAART regimen with at least 2 ARVs to which his/her virus show sensitivity by genotypic testing at screening (Genotypic Sensitivity Score or GSS =2).

4. Must be willing and able to give written informed consent

5. Must be willing and able to abide by the conditions of the protocol, including the possibility of being randomized to HAART or ENF+HAART as described in the Induction Phase as well as possibly being randomized to either stop or continue ENF in the Maintenance Phase

6. Female subjects of childbearing potential must have a negative serum pregnancy test documented during screening for eligibility, and a negative urine pregnancy test within 24 hours prior to first dose of study medication. Female subjects of childbearing potential must agree to use a reliable form of effective barrier contraception (< 1% failure rate) for the duration of the study, and for 30 days after the last dose of study drug, or have documented sterility

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Expected systemic hypersensitivity to enfuvirtide or to any of the excipients of the investigational medicinal product.
2. History of prior use of enfuvirtide and/or T-1249
3. Patients for whom standard of care, in the judgment of the investigator, would require immediate use of enfuvirtide or medications not permitted in the protocol.
4. Patients on treatment interruption or patients interrupting ARV therapy within 4 weeks of screening or during the screening period for reasons other than toxicity management.
5. Female subjects who are pregnant, breastfeeding, or who plan to become pregnant during the study.
6. Any current clinical parameter of ACTG Grade 3 or laboratory parameter of ACTG Grade 4. Stable current clinical parameter of ACTG Grade 3 or Asymptomatic Grade 4 laboratory abnormalities will be permitted, at the discretion of the investigator (and following approval by the sponsor), if deemed clinically appropriate.
7. Evidence of alcohol and/or drug (illicit or prescription) abuse within one year of entry that, in the judgment of the investigator, would result in the subject being unreliable in fulfilling the conditions of the protocol.
8. Prior non-adherence to antiretroviral treatment regimens that, in the judgment of the investigator, would result in the subject being unreliable in fulfilling the conditions of the protocol.
9. Inability to self-inject enfuvirtide as indicated in the protocol unless a care giver or partner/family member is available to be trained and to administer the injections for the duration of the study.
10. Current severe illness or any other conditions which would make the subject, in the opinion of the investigator, unsuitable for the study.
11. Major organ allograft.
12. Evidence of active, untreated opportunistic infection (including any abnormality on fundoscopic examination, unless deemed benign by an ophthalmologist), or unexplained temperature which is greater than or equal to 38.5 degrees C for seven consecutive days, within 30 days prior to the screening visit. Subjects who are on a stable anti-infective treatment or prophylaxis regimen are allowed in the study.
13. Currently taking or anticipated to take during the course of the study, any immunomodulator, HIV vaccine, or investigational agent for any conditions other than HIV/AIDS.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified