Evaluation of 3TC or FTC Mono-therapy Compared to Continuing HAART as a Bridging Strategy (P1094)

This study has been terminated.

(Study was halted for lack of accrual)

Sponsor:

Collaborators:

National Institute of Allergy and Infectious Diseases (NIAID)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by (Responsible Party):

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

ClinicalTrials.gov Identifier:

NCT01338025

First received: April 16, 2011

Last updated: October 14, 2015

Last verified: October 2015

History of Changes

Results First Received: April 24, 2014

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	HIV Disease
Interventions:	Drug: HAART regimen Drug: 3TC or FTC monotherapy

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from 17 sites in the United States, Argentina, Brazil and Thailand. Enrollment occurred from May 10, 2011 to January 16, 2013.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible participants were HIV-infected, ≥8 to <25 years of age with documentation of the M184V HIV resistance mutation, were failing their current antiretroviral regimen and were persistently non-adherent. Participants were randomized equally to the two study arms.

Reporting Groups

	Description
Arm A, Non-suppressive HAART Regimen	In Step 1, subjects were randomized to continue their non-suppressive HAART regimen. In Step 2, subjects either began a new HAART regimen, continue randomized treatment, or discontinued therapy while remaining on follow-up, as decided by their provider. HAART regimen: The study participant continued their non-suppressive HAART regimen as prescribed by their primary provider.
Arm B, 3TC or FTC Monotherapy	In step 1, subjects were randomized to receive 3TC or FTC (the choice of 3TC or FTC was left to the provider.) In Step 2, subjects either began a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider. 3TC or FTC monotherapy: The study participant was assigned to either 3TC or FTC monotherapy (the choice of 3TC or FTC was left to the provider.)

Description

Arm A, Non-suppressive HAART Regimen

In Step 1, subjects were randomized to continue their non-suppressive HAART regimen.

In Step 2, subjects either began a new HAART regimen, continue randomized treatment, or discontinued therapy while remaining on follow-up, as decided by their provider.

HAART regimen: The study participant continued their non-suppressive HAART regimen as prescribed by their primary provider.

Arm B, 3TC or FTC Monotherapy

In step 1, subjects were randomized to receive 3TC or FTC (the choice of 3TC or FTC was left to the provider.) In Step 2, subjects either began a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.

3TC or FTC monotherapy: The study participant was assigned to either 3TC or FTC monotherapy (the choice of 3TC or FTC was left to the provider.)

Participant Flow: Overall Study

	Arm A, Non-suppressive HAART Regimen	Arm B, 3TC or FTC Monotherapy
STARTED	16	17
COMPLETED	5	6
NOT COMPLETED	11	11
Unexpected closure of study	10	9
Withdrawal by Subject	0	2
Found ineligible after starting	1	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All eligible participants who entered the study were included in analyses. One participant on Arm A did not meet entry eligibility criteria; was taken off study after the entry visit, and is therefore excluded from all analyses.

Reporting Groups

	Description
Arm A, Non-suppressive HAART Regimen	In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen as prescribed by their primary provider. In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.
Arm B, 3TC or FTC Monotherapy	In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider). In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.
Total	Total of all reporting groups

Description

Arm A, Non-suppressive HAART Regimen

In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen as prescribed by their primary provider.

In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.

Arm B, 3TC or FTC Monotherapy

In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider).

In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.

Total

Total of all reporting groups

Baseline Measures

	Arm A, Non-suppressive HAART Regimen	Arm B, 3TC or FTC Monotherapy	Total
Overall Participants Analyzed [Units: Participants]	15	17	32

Age [Units: Participants]
<=18 years	7	11	18
Between 18 and 65 years	8	6	14
>=65 years	0	0	0

Gender [Units: Participants]
Female	11	10	21
Male	4	7	11

Ethnicity (NIH/OMB) [Units: Participants]
Hispanic or Latino	6	8	14
Not Hispanic or Latino	8	9	17
Unknown or Not Reported	1	0	1

Race (NIH/OMB) [Units: Participants]
American Indian or Alaska Native	0	0	0
Asian	2	3	5
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	9	8	17
White	4	6	10
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Region of Enrollment [Units: Participants]
United States	9	9	18
Argentina	2	1	3
Brazil	1	4	5
Thailand	3	3	6

Screening CD4 count [Units: Cells/mm3] Mean (Standard Deviation)	509 (176)	511 (277)	510 (232)

HIV-1 RNA viral load [Units: Log10 copies/mL] Mean (Standard Deviation)	4.0 (1.0)	3.8 (0.7)	3.9 (0.9)