A randomized, exploratory, open-label 48-week trial with a 2-week Pre-Treatment Phase to investigate the pharmacokinetics, safety, tolerability and antiviral activity of etravirine (ETR) in combination with ritonavir-boosted atazanavir (ATV/rtv) and 1 NRTI in treatment-experienced HIV-1 infected subjects

Phase 1

Active, not recruiting

• Conditions: HIV-1 infection; MedDRA version: 9.1Level: LLTClassification code 10020192Term: HIV-1

• Registration Number: EUCTR2009-010887-41-FR
• Lead Sponsor: Tibotec Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-15
• Study Completion: 2012-04-10
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1. Male or female subjects, aged 18 years or above.
2. Subject has signed the informed consent form (ICF) voluntarily.
3. Subject can comply with the protocol requirements.
4. Subject with documented HIV-1 infection.
5. HIV-1 plasma viral load at Screening Visit above 500 HIV-1 RNA copies/mL.
6. Subject has received at least one HAART regimen
Note: HAART is defined as potent anti-HIV treatment usually including a combination
of 3 or more drugs with activity against HIV whose purpose is to reduce viral load to
undetectable. This regimen usually includes treatment with at least 2 NRTIs in
combination with at least 1 additional ARV from the NNRTI and/or PI class.
Note: Subjects on a structured treatment interruption for a minimum of 4 weeks at the time of screening are allowed.
7. On a stable antiretroviral therapy (ART) for at least 8 weeks at Screening and willing to stay on that treatment until the start of the Pre-Treatment Phase.
8. Presence of at least 1 of the following mutations (based upon the following list of
47 NNRTI RAMs: V90I, A98G, L100I, K101E/H/P/Q, K103H/N/S/T, V106A/I/M,
V108I, E138A/G/K/Q, V179D/E/F/G/I/T, Y181C/I/V, Y188C/H/L, V189I,
G190A/C/E/Q/S, H221Y, P225H, F227C/L, M230I/L, P236L, K238N/T, Y318F) on the
resistance test at Screening or from prior genotypic analysis, evidence of which should be available in the source documents and enrollment of the subject based on these data needs to be agreed upon by the sponsor.
9. Demonstrated sensitivity to ATV, ETR and at least one of the selected NRTIs based on the resistance test at Screening.
10.General medical condition, in the investigator’s opinion, does not interfere with the assessments and completion of the trial.
Subjects who meet all of the criteria above and the following criteria are eligible for the
substudy:
1. Currently enrolled in trial TMC125-C238 for > 24 weeks.
2. Informed Consent Form (ICF) signed voluntarily.
3. HIV-1 plasma viral load < 50 copies/mL on at least the 2 most recent consecutive visits.
4. General medical condition, in the investigator’s opinion, does not interfere with the
assessments and completion of the substudy.
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. Primary HIV-1 infection.
2. Previously documented HIV-2 infection.
3. Previously failed 2 or more HIV PI-containing regimens.
4. Use of disallowed concomitant therapy.
5. Previous diagnosis of hereditary hyperbilirubinemia (eg. Gilbert’s syndrome, Crigler- Najjar syndrome).
6. Any condition (including but not limited to alcohol and drug use) which, in the opinion of the investigator, could compromise the subject’s safety or adherence to the protocol.
7. Life expectancy less than 6 months according to the judgment of the investigator.
8. Subject has any currently active AIDS defining illness with the following exceptions, which must be discussed with the sponsor prior to enrollment:
a. Stable cutaneous Kaposi’s Sarcoma (i.e., no pulmonary or gastrointestinal
involvement other than oral lesions) that is unlikely to require any form of
systemic therapy during the trial period.
b. Wasting syndrome due to HIV infection if, in the investigator’s opinion, it is not
actively progressive and its treatment does not require hospitalization or
compromise the subject’s safety or compliance to adhere to trial related
procedures.
Note: An AIDS defining illness not clinically stabilized for at least 30 days will be
considered clinically active. Primary and secondary prophylaxis for an AIDS defining
illness is allowed in case the medication used is not part of the disallowed medication.
9. Any active clinically significant disease (e.g., pancreatitis, cardiac dysfunction) or
findings during screening of medical history, laboratory or physical examination that, in the investigator’s opinion, would compromise the subject’s safety or outcome of the trial.
10. Acute viral hepatitis including but not limited to A, B, or C.
11. Chronic hepatitis B and/or C co-infection.
12. Receipt of an investigational drug or investigational vaccine within 30 days prior to the trial drug administration.
13. Previously demonstrated clinically significant allergy or hypersensitivity to ETR or to any of the excipients of ETR.
14. Pregnant or breastfeeding female subject.
15. Female subject of childbearing potential not using effective birth control methods or not willing to continue practicing these birth control methods during the trial and for at least 30 days after the end of the trial (or after last intake of investigational medication;
Note: Hormone-based contraception may not be reliable when taking ARV agents;
therefore, to be eligible for this trial, women of childbearing potential should either:
• use a double barrier method to prevent pregnancy (i.e., using a male condom with
diaphragm or cervical cap); or
• use an hormonal contraceptive in combination with a barrier contraceptive (i.e.,
female/male condom, diaphragm or cervical cap); or
• use an intrauterine device (IUD) in combination with a barrier contraceptive (i.e.,
female/male condom, diaphragm or cervical cap); or
• do not engage in heterosexual sex, or have a vasectomized partner with confirmed
sterility.
Note: Women who are postmenopausal for at least 2 years and women with surgical
sterilization, i.e., tubal ligation or total hysterectomy, are considered of non-childbearing
potential.
Note: Spermicides contain non-oxynol-9 and should not be used as this can potentially
increase the rate of HIV-1 transmission.
Note: Use of an IUD can increase the risk of sexually transmitted infections, including
HIV.
16. Non-vasectomized heterosexually active male subject not using effective birth control methods or no

Study & Design

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