In Step 1, subjects were randomized to continue their non-suppressive HAART regimen.
In Step 2, subjects either began a new HAART regimen, continued randomized treatment, or discontinued therapy while remaining on follow-up, as decided by their provider.

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, continued randomized treatment, or discontinued therapy while remaining on follow-up, as decided by their provider.

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 A, Non-suppressive HAART Regimen

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.

Arm B, 3TC or FTC Monotherapy

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Screening CD4 count

HIV-1 RNA viral load

Immunologic deterioration was declared for a participant if any one of the following conditions is observed within the first 28 weeks:
greater than or equal to 30% decline in absolute CD4+ T cell count from entry, or
development of CDC class C events.
Results report number of participants with immunologic deterioration at week 28 calculated.

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

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.
3TC or FTC monotherapy: The study participant will be assigned to either 3TC/FTC monotherapy (the choice of 3TC or FTC will be left to the provider.

Number of Participants With Immunologic Deterioration

Change in CD4+ T cell count from entry to Week 28 (CD4+ at entry - CD4+ at Week 28).

Change in CD4+ T Cell Count

Change in HIV-1 RNA levels from Entry to Week 28

Change in HIV-1 RNA Levels

Number of participants reporting a missed medication dose in the past 3 days.

Number of Participants Non-adherent as Measured by 3-day Recall

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.

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.)

Overall Study

Melissa Allen, Director, IMPAACT Operations Center

HIV Disease

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

HAART regimen

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

3TC or FTC monotherapy

Univ. of California San Francisco NICHD CRS (5091)

Children's National Med. Ctr. Washington DC NICHD CRS (5015)

University of Florida (5051)

Univ of Miami Pediatric/Perinatal HIV/AIDS (4201)

Chicago Children's CRS (4001)

Johns Hopkins University NICHD CRS (5092)

Bronx-Lebanon Hospital (6901)

Metropolitan Hospital (5003)

SUNY Stony Brook NICHD CRS (5040)

DUMC Ped. CRS (4701)

Hospital General de Agudos Buenos Aires Argentina NICHD CRS (5082)

Hospital Geral De Nova Igaucu Brazil NICHD CRS (5097)

Insituto de Infectologia Emilio Ribas NICHD CRS (5075)

Univ of Sao Paulo Brazil NICHD CRS (5074)

University of Puerto Rico Pediatric HIV/AIDS Research (6601)

Siriraj Hospital Mahidol University CRS (8251)

Chiang Mai University Pediatrics-Obstetrics CRS (20101)

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

Evaluation of 3TC or FTC Mono-therapy Compared to Continuing HAART as a Bridging Antiretroviral Strategy in Persistently Non-adherent Children, Adolescents, and Young Adults Who Are Failing HAART and Have the M184V Resistance Mutation.

bola/protease

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

Išsamiausia vaistinių žolelių duomenų bazė, paremta mokslu