A clinical trial to study the effects and the antiviral activity of TMC278 in HIV-1 infected adolescent patients aged 12 to 18 years

Phase 2

Recruiting

• Conditions: Health Condition 1: null- HIV 1 infected adolescents

• Registration Number: CTRI/2011/06/001796
• Lead Sponsor: Johnson and johnson Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 35

Inclusion Criteria

1.Boys or girls, aged 12 to 18 years.

2. Subject?s weight is more thanor equal to 32 kg.

3. Subject with documented chronic HIV-1 infection who is aware of his/her HIV-1 diagnosis.

4.Subject has,prior to screening, never been treated with a therapeutic HIV vaccine or an

HIV drug with the exception of a single dose of NVP to prevent MTCT.

5. HIV-1 plasma viral load at screening 5,000 HIV1 RNA copies/mL (assayed by RNA polymerase chain reaction, standard specimen procedure).

6. In the judgment of the investigator, it is appropriate to initiate ARV therapy based on the

subject?s medical condition and taking into account guidelines for the treatment of HIV-1

infection in children of this age group.

Note: Most current treatment guidelines recommend considering initiation of ART when

CD4+ cell counts are less than 350 cells/mm³. However, clinical situations may warrant

initiating ART with CD4+ cell counts 350 cells/mm³.

7. Results from the screening virco® TYPE HIV-1 demonstrate sensitivity to the selected

N(t)RTIs using the lower CCO (indicated as ?maximal response? on the screening TYPE HIV-1 result) or the BCO (indicated as ?susceptible?), whichever is applicable for the chosen background regimen.

8. The subject agrees (or their parents/caregivers agree, in case the subjects age is below the cut-off age for consent according to local regulations, in which case the subject is informed and asked to give positive assent) not to start ART before the baseline visit.

9.General medical condition, in the investigator?s opinion, does not interfere with the assessments and the completion of the trial.

Exclusion Criteria

Subjects meeting one or more of the following criteria cannot be selected:

1. Any previous use of ARVs, with the exception of a single dose of NVP to prevent MTCT.

Note: Subjects who were infected by MTCT are allowed to enter, provided the mother

was ARV treatment-naïve at the time of delivery with the exception of NVP for no

more than 3 days.

2. Having documented genotypic evidence of NNRTI resistance at screening or from

historical data available in the source documents, i.e., 1 NNRTI RAM from the

following list (the list was compiled on the basis of the list of IAS-USA NNRTI RAMs23

and other relevant publications).

A098G V106M Y181C G190S

L100I V108I Y181I G190T

K101E E138A Y181V P225H

K101P E138G Y188C F227C

K101Q E138K Y188H M230I

K103H E138Q Y188L M230L

K103N E138R G190A P236L

K103S V179E G190C K238N

K103T V179D G190E K238T

V106A V179T G190Q Y318F

3. Previously documented HIV-2 infection.

4. Subject has a positive HLA-B5701 test at screening (when the invesigator considers

ABC/3TC as a background regimen). In case of a positive test, ABC/3TC cannot be

administered, but instead, the investigator can select AZT/3TC as the background

regimen. HLA-B5701 testing is not required for subjects with prior documented

negative results.

5. Use of disallowed concomitant therapy from 4 weeks prior to the baseline visit.

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.

Date

Subject has any currently active Acquired Immunodeficiency Syndrome (AIDS) defining

illness (Category C conditions according to the Centers for Disease Control and

Prevention [CDC] Classification System for HIV-Infection 1993).

Note: An AIDS defining illness not clinically stabilized for at least 30 days will be

considered as clinically active.

Note: Primary or 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, active and significant psychiatric disorders, clinical suspicion of adrenal insufficiency, hepatic

impairment), or findings during screening or medical history that in the investigator?s

opinion, would compromise the outcome of the trial.

10. Subject has a known or suspected acute (primary) HIV-1 infection.

11. Any current or history of adrenal disorder.

12. Previously demonstrated clinically significant allergy or hypersensitivity to any of the components of the investigational medication (TMC278) or the selected NRTIs. In this

last case, the other N(t)RTI may be selected.

13. Receipt of any investigational drug or investigational vaccine within 90 days prior to the first administration of TMC278.

14. Pregnant or breastfeeding girl.

15. Heterosexually active girls of childbearing potential without the use of effective birth

control methods or not willing to continue practicing these birth control methods from

screening onwards until at least 30 days after last intake of TMC278.

Girls of childbearing

Study & Design

• Study Type: Interventional
• Study Design: Not specified