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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01338025
• Date of registration: 16/04/2011
• Prospective Registration: No
• Primary sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
• Public title: Evaluation of 3TC or FTC Mono-therapy Compared to Continuing HAART as a Bridging Strategy P1094
• Scientific title: 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.
• Date of first enrolment: March 2011
• Target sample size: 33
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01338025
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

Argentina, Botswana, Brazil, India, Malawi, Puerto Rico, South Africa, Tanzania, Thailand, Uganda, United States, Zambia, Zimbabwe

Contacts

• Name: Allison L. Agwu, MD, Sc.M.
• Affiliation: Johns Hopkins University

Key inclusion & exclusion criteria

Step 1 Inclusion Criteria:

- Age greater than or equal to 8 to less than 25 years of age, at study entry

- Documentation of HIV-1 infection defined as positive results from two samples
collected at different time points

- Treatment experienced patients must have demonstrated failure on the current HAART
regimen for 2 months or longer. These patients must have been on ARVs for at least a
total of 6 months prior to entry. Thus, if the failing regimen was the first ARV
regimen, then the patient must have been on that initial regimen for a minimum of 6
months total.

- CD4+ T cell count greater than or equal to 100 cells/mm3 (confirmed on at least two
occasions within 6 months of study entry, including the screening value)

- Documentation of the M184V mutation on genotypic testing at any time prior to study
entry

- In the best judgment of the clinical site team, concerns about the subject's ability
to adhere made it unsuitable to initiate a new optimal HAART regimen for at least 6
months.

- Subject had not become adherent despite site's adherence interventions

- Female subjects of reproductive potential engaging in sexual activity that could lead
to pregnancy had to agree to avoid pregnancy during the entire 52 week trial and to
consistently and appropriately use at least two of the following contraception
methods: condoms, diaphragm or cervical cap with spermicide, IUD, hormonal-based
contraception. A list of acceptable methods can be found at the FDA Birth Control
Guide (http://www.fda.gov/womens).

- Parent/legal guardian or subject able and willing to provide signed informed consent
when applicable

Step 1 Exclusion Criteria:

- Positive hepatitis B surface antigen or known active hepatitis B infection.

- Pregnant or breastfeeding.

- Active malignancy within the past 2 years.

- Current immunosuppressive therapy, including the equivalent of greater than 1
mg/kg/per day or greater than 20 mg total daily dose of prednisone in the 2 weeks
preceding screening. Subjects for whom long-term systemic corticosteroid therapy
(greater than 2 weeks) was anticipated were excluded. [Note: non-steroidal
anti-inflammatory agents and inhaled, nasal, and topical corticosteroids were not
excluded as immunosuppressive therapy.]

- Prior immunization with an HIV-specific vaccine

- Greater than or equal to 1 CDC class C event within the past 12 months.

- Renal disease (as defined by estimated creatinine clearance less than 50 mL/min/1.73m2
confirmed on two occasions within 3 months of screening).

- Active opportunistic infections, including active tuberculosis (TB).

- Current treatment for active systemic TB. If recent, infection must have completed
treatment course. INH treatment for latent TB is allowed.

- Viral load greater than 250,000 copies/mL at screening.

- Known greater than or equal than Grade 3 of any of the following laboratory toxicities
within 30 days prior to study entry: neutrophil count, hemoglobin, platelets, AST,
ALT, lipase, serum creatinine. Note: Subjects could be re-screened and enrolled if
repeat value was less than Grade 3 without signs or symptoms of related organ
dysfunction.

- Known greater than or equal to Grade 4 laboratory toxicities within 30 days prior to
study entry, except with approval of the study team.

- For subjects who were not taking 3TC or FTC at the time of screening: Documented prior
intolerance or adverse effect reasonably attributed to 3TC or FTC that resulted in
permanent discontinuation.

- Problems with non-adherence attributed to modifiable structural barriers, such as lack
of resources (e.g., insurance, transportation).

Step 2 - Inclusion Criteria

- Met requirements for completion of Step 1

- Subject/guardian agree to continue participation in Step 2

- ViroSeq assay results had been received by site and reviewed by investigator



Age minimum: 8 Years
Age maximum: 24 Years
Gender: All

Health Condition(s) or Problem(s) studied

HIV Disease

Intervention(s)

Drug: HAART regimen

Drug: 3TC or FTC monotherapy

Primary Outcome(s)

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

Secondary Outcome(s)

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

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

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

Secondary ID(s)

U01AI068632

IMPAACT P1094

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Allergy and Infectious Diseases (NIAID)

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

Results

• Results available: Yes
• Date Posted: 23/05/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01338025