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

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (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.)

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

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)

  Outcome Measures

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1. Primary:

Number of Participants With Immunologic Deterioration [ Time Frame: From entry to week 28 ]

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2. Secondary:

Change in CD4+ T Cell Count [ Time Frame: Entry to week 28 ]

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3. Secondary:

Change in HIV-1 RNA Levels [ Time Frame: 28 Weeks ]

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4. Secondary:

Number of Participants Non-adherent as Measured by 3-day Recall [ Time Frame: 28 Weeks ]

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  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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