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

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ClinicalTrials.gov Identifier: NCT01338025
Recruitment Status : Terminated (Study was halted for lack of accrual)
First Posted : April 19, 2011
Results First Posted : May 23, 2014
Last Update Posted : November 13, 2015
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

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
Enrollment 33
Recruitment Details 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 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.
Arm/Group Title Arm A, Non-suppressive HAART Regimen Arm B, 3TC or FTC Monotherapy
Hide Arm/Group Description

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.)

Period Title: Overall Study
Started 16 17
Completed 5 6
Not Completed 11 11
Reason Not Completed
Unexpected closure of study             10             9
Withdrawal by Subject             0             2
Found ineligible after starting             1             0
Arm/Group Title Arm A, Non-suppressive HAART Regimen Arm B, 3TC or FTC Monotherapy Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 15 17 32
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 32 participants
<=18 years
7
  46.7%
11
  64.7%
18
  56.3%
Between 18 and 65 years
8
  53.3%
6
  35.3%
14
  43.8%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 32 participants
Female
11
  73.3%
10
  58.8%
21
  65.6%
Male
4
  26.7%
7
  41.2%
11
  34.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 32 participants
Hispanic or Latino
6
  40.0%
8
  47.1%
14
  43.8%
Not Hispanic or Latino
8
  53.3%
9
  52.9%
17
  53.1%
Unknown or Not Reported
1
   6.7%
0
   0.0%
1
   3.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 32 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
  13.3%
3
  17.6%
5
  15.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
9
  60.0%
8
  47.1%
17
  53.1%
White
4
  26.7%
6
  35.3%
10
  31.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 32 participants
United States 9 9 18
Argentina 2 1 3
Brazil 1 4 5
Thailand 3 3 6
Screening CD4 count  
Mean (Standard Deviation)
Unit of measure:  Cells/mm3
Number Analyzed 15 participants 17 participants 32 participants
509  (176) 511  (277) 510  (232)
HIV-1 RNA viral load  
Mean (Standard Deviation)
Unit of measure:  Log10 copies/mL
Number Analyzed 15 participants 17 participants 32 participants
4.0  (1.0) 3.8  (0.7) 3.9  (0.9)
1.Primary Outcome
Title Number of Participants With Immunologic Deterioration
Hide Description

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.

Time Frame From entry to week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm A, Non-suppressive HAART Regimen Arm B, 3TC or FTC Monotherapy
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 15 17
Measure Type: Number
Unit of Measure: participants
0 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A, Non-suppressive HAART Regimen, Arm B, 3TC or FTC Monotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Change in CD4+ T Cell Count
Hide Description Change in CD4+ T cell count from entry to Week 28 (CD4+ at entry - CD4+ at Week 28).
Time Frame Entry to week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible participants with CD4+ cell count results available at entry and at week 28.
Arm/Group Title Arm A, Non-suppressive HAART Regimen Arm B, 3TC or FTC Monotherapy
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 6 8
Median (Inter-Quartile Range)
Unit of Measure: CD4+ T cell count/mL
27.5
(-44 to 45)
76
(1.5 to 222)
3.Secondary Outcome
Title Change in HIV-1 RNA Levels
Hide Description Change in HIV-1 RNA levels from Entry to Week 28
Time Frame 28 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible participants with HIV-1 RNA results available at entry and at week 28.
Arm/Group Title Arm A, Non-suppressive HAART Regimen Arm B, 3TC or FTC Monotherapy
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 8 6
Median (Inter-Quartile Range)
Unit of Measure: copies/mL
3087
(-3,000 to 17,761)
-2241
(-20,354 to -680)
4.Secondary Outcome
Title Number of Participants Non-adherent as Measured by 3-day Recall
Hide Description Number of participants reporting a missed medication dose in the past 3 days.
Time Frame 28 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible participants with adherence data available at week 28.
Arm/Group Title Arm A, Non-suppressive HAART Regimen Arm B, 3TC or FTC Monotherapy
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 6 7
Measure Type: Number
Unit of Measure: participants
3 1
Time Frame From study enrollment until study completion or discontinuation.
Adverse Event Reporting Description Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
 
Arm/Group Title Arm A, Non-suppressive HAART Regimen Arm B, 3TC or FTC Monotherapy
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Arm A, Non-suppressive HAART Regimen Arm B, 3TC or FTC Monotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm A, Non-suppressive HAART Regimen Arm B, 3TC or FTC Monotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A, Non-suppressive HAART Regimen Arm B, 3TC or FTC Monotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   15/16 (93.75%)   15/17 (88.24%) 
Blood and lymphatic system disorders     
Iron deficiency anaemia  1  0/16 (0.00%)  1/17 (5.88%) 
Cardiac disorders     
Bradycardia  1  0/16 (0.00%)  1/17 (5.88%) 
Ear and labyrinth disorders     
Cerumen impaction  1  1/16 (6.25%)  0/17 (0.00%) 
Ear pain  1  1/16 (6.25%)  1/17 (5.88%) 
Otorrhoea  1  0/16 (0.00%)  1/17 (5.88%) 
Eye disorders     
Conjunctivitis  1  0/16 (0.00%)  2/17 (11.76%) 
Gastrointestinal disorders     
Diarrhoea  1  0/16 (0.00%)  1/17 (5.88%) 
Flatulence  1  1/16 (6.25%)  0/17 (0.00%) 
Nausea  1  2/16 (12.50%)  1/17 (5.88%) 
Vomiting  1  2/16 (12.50%)  0/17 (0.00%) 
General disorders     
Axillary pain  1  1/16 (6.25%)  0/17 (0.00%) 
Chest discomfort  1  0/16 (0.00%)  1/17 (5.88%) 
Chest pain  1  1/16 (6.25%)  0/17 (0.00%) 
Fatigue  1  0/16 (0.00%)  1/17 (5.88%) 
Malaise  1  1/16 (6.25%)  0/17 (0.00%) 
Pyrexia  1  1/16 (6.25%)  1/17 (5.88%) 
Infections and infestations     
Acarodermatitis  1  0/16 (0.00%)  1/17 (5.88%) 
Body tinea  1  0/16 (0.00%)  1/17 (5.88%) 
Cutaneous larva migrans  1  1/16 (6.25%)  0/17 (0.00%) 
Ear infection bacterial  1  1/16 (6.25%)  0/17 (0.00%) 
Furuncle  1  1/16 (6.25%)  0/17 (0.00%) 
Hordeolum  1  0/16 (0.00%)  1/17 (5.88%) 
Impetigo  1  0/16 (0.00%)  1/17 (5.88%) 
Infection protozoal  1  0/16 (0.00%)  1/17 (5.88%) 
Lice infestation  1  1/16 (6.25%)  0/17 (0.00%) 
Nasopharyngitis  1  0/16 (0.00%)  1/17 (5.88%) 
Otitis externa  1  0/16 (0.00%)  1/17 (5.88%) 
Otitis media  1  1/16 (6.25%)  0/17 (0.00%) 
Pharyngitis  1  2/16 (12.50%)  0/17 (0.00%) 
Pneumonia  1  1/16 (6.25%)  0/17 (0.00%) 
Purulent discharge  1  0/16 (0.00%)  1/17 (5.88%) 
Rash pustular  1  0/16 (0.00%)  1/17 (5.88%) 
Skin bacterial infection  1  1/16 (6.25%)  0/17 (0.00%) 
Subcutaneous abscess  1  1/16 (6.25%)  0/17 (0.00%) 
Tonsillitis  1  0/16 (0.00%)  2/17 (11.76%) 
Vaginitis bacterial  1  0/16 (0.00%)  1/17 (5.88%) 
Injury, poisoning and procedural complications     
Ligament sprain  1  1/16 (6.25%)  0/17 (0.00%) 
Post procedural complication  1  1/16 (6.25%)  0/17 (0.00%) 
Procedural pain  1  1/16 (6.25%)  0/17 (0.00%) 
Investigations     
Alanine aminotransferase abnormal  1  1/16 (6.25%)  1/17 (5.88%) 
Alanine aminotransferase increased  1  1/16 (6.25%)  2/17 (11.76%) 
Aspartate aminotransferase abnormal  1  1/16 (6.25%)  1/17 (5.88%) 
Aspartate aminotransferase increased  1  1/16 (6.25%)  3/17 (17.65%) 
Blood alkaline phosphatase abnormal  1  1/16 (6.25%)  1/17 (5.88%) 
Blood alkaline phosphatase increased  1  1/16 (6.25%)  1/17 (5.88%) 
Blood bicarbonate decreased  1  1/16 (6.25%)  1/17 (5.88%) 
Blood bilirubin increased  1  3/16 (18.75%)  0/17 (0.00%) 
Blood cholesterol increased  1  4/16 (25.00%)  1/17 (5.88%) 
Blood creatinine increased  1  1/16 (6.25%)  1/17 (5.88%) 
Blood glucose abnormal  1  0/16 (0.00%)  1/17 (5.88%) 
Blood glucose decreased  1  1/16 (6.25%)  0/17 (0.00%) 
Blood potassium decreased  1  1/16 (6.25%)  0/17 (0.00%) 
Blood sodium decreased  1  0/16 (0.00%)  2/17 (11.76%) 
Haemoglobin decreased  1  1/16 (6.25%)  1/17 (5.88%) 
Lipase abnormal  1  1/16 (6.25%)  2/17 (11.76%) 
Low density lipoprotein increased  1  3/16 (18.75%)  2/17 (11.76%) 
Neutrophil count decreased  1  4/16 (25.00%)  1/17 (5.88%) 
Platelet count decreased  1  0/16 (0.00%)  3/17 (17.65%) 
Metabolism and nutrition disorders     
Decreased appetite  1  0/16 (0.00%)  1/17 (5.88%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  0/16 (0.00%)  1/17 (5.88%) 
Neck pain  1  1/16 (6.25%)  0/17 (0.00%) 
Pain in extremity  1  0/16 (0.00%)  1/17 (5.88%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Skin papilloma  1  1/16 (6.25%)  0/17 (0.00%) 
Nervous system disorders     
Headache  1  1/16 (6.25%)  0/17 (0.00%) 
Hypoaesthesia  1  1/16 (6.25%)  0/17 (0.00%) 
Sinus headache  1  1/16 (6.25%)  0/17 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Pregnancy  1  1/16 (6.25%)  0/17 (0.00%) 
Psychiatric disorders     
Oppositional defiant disorder  1  0/16 (0.00%)  1/17 (5.88%) 
Renal and urinary disorders     
Dysuria  1  0/16 (0.00%)  1/17 (5.88%) 
Reproductive system and breast disorders     
Cervical dysplasia  1  0/16 (0.00%)  1/17 (5.88%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  2/16 (12.50%)  0/17 (0.00%) 
Cough  1  3/16 (18.75%)  2/17 (11.76%) 
Nasal congestion  1  1/16 (6.25%)  0/17 (0.00%) 
Oropharyngeal discomfort  1  0/16 (0.00%)  1/17 (5.88%) 
Oropharyngeal pain  1  2/16 (12.50%)  0/17 (0.00%) 
Respiratory tract congestion  1  1/16 (6.25%)  0/17 (0.00%) 
Rhinorrhoea  1  1/16 (6.25%)  0/17 (0.00%) 
Wheezing  1  1/16 (6.25%)  1/17 (5.88%) 
Skin and subcutaneous tissue disorders     
Dermatitis atopic  1  0/16 (0.00%)  1/17 (5.88%) 
Papule  1  0/16 (0.00%)  1/17 (5.88%) 
Pruritus  1  0/16 (0.00%)  1/17 (5.88%) 
Rash  1  0/16 (0.00%)  1/17 (5.88%) 
Skin disorder  1  1/16 (6.25%)  0/17 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Melissa Allen, Director, IMPAACT Operations Center
Organization: Family Health International (FHI 360)
Phone: (919) 405-1429
Responsible Party: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01338025     History of Changes
Other Study ID Numbers: IMPAACT P1094
U01AI068632 ( U.S. NIH Grant/Contract )
First Submitted: April 16, 2011
First Posted: April 19, 2011
Results First Submitted: April 24, 2014
Results First Posted: May 23, 2014
Last Update Posted: November 13, 2015