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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01761643
Other study ID # CCTG 595
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 19, 2012
Est. completion date July 11, 2018

Study information

Verified date June 2020
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

CCTG 595 is a controlled, open-label, two-arm, randomized (1:1) clinical demonstration project to determine if the use of a text-message based adherence intervention (iTAB) improves retention and adherence to PrEP compared to standard of care (SoC) PrEP delivery.


Description:

A total of 400 HIV-uninfected men who have sex with men (MSM)and male to female (M to F) transgender individuals with recent high-risk transmission behavior will be enrolled into the study. Each subject will be followed for up to 48 weeks after enrollment of the last subject. The primary endpoint will be measured at 48 weeks.

All subjects will start PrEP with TDF + FTC fixed dose combination given once daily. Subjects will be randomized (1:1) to either the iTAB text messaging adherence reminder intervention with SoC or the SoC alone arm. Subjects placed into the iTAB intervention arm will receive a personalized, automated texting system to maintain adherence and retention. Both groups will receive access to PrEP in accordance with standardized comprehensive methods of prescribing, risk reduction counseling, adherence counseling, and clinical assessments that include safety monitoring, as well as HIV and STD screening.

TDF 300 mg + FTC 200 mg fixed dose combination will be given orally once daily starting at the baseline visit (month 0) and continued throughout the study.


Recruitment information / eligibility

Status Completed
Enrollment 398
Est. completion date July 11, 2018
Est. primary completion date June 13, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Man or transgender M to F who has sex with men.

- Age 18 years or older.

- Subjects must have substantial ongoing risk of acquisition of HIV as evident by one or more of the following:

- Has at least one HIV infected sexual partner for =4 weeks.

- No condom use during anal intercourse with =3 male sex partners who are HIV-positive or of unknown HIV status during the last 3 months.

- No condom use during anal sex with =1 male partner and STI diagnosis during the last 3 months.

- Negative for HIV infection by rapid HIV test and confirmed negative by NAT or other sensitive method such as antibody- antigen test.

- Acceptable laboratory values in the past 30 days:

- Calculated creatinine clearance of at least 60 mL/min by the Cockcroft-Gault formula (eCcr (male) in mL/min = [(140 - age in years) x (lean body weight in kg)] / (72 x serum creatinine in mg/dL)

- Alanine aminotransferase (ALT) and/ or aspartate aminotransferase (AST) < 3 x upper limit of normal (ULN)

- Hemoglobin > 9 g/dL

- Absolute neutrophil count > 750/ mm3

- Platelets > 75,000/ mm3

Exclusion Criteria:

- Unable to give informed consent.

- Active hepatitis B (positive hepatitis B surface antigen (HBSAg) or HBSAg negative/ HB core antibody positive/ HBV PCR positive).

- Has substantial medical condition, that in the opinion of the investigator would preclude participation, as defined by

- cardiovascular condition that may lead to an increased risk of complication if placed on study drugs.

- gastrointestinal condition that would impair absorption of study drugs.

- neurological or psychiatric condition that would significantly impair the ability to adhere to PrEP.

- calculated GFR < 60 mL/min.

- alcohol or drug abuse or dependence that would significantly impair the ability to adhere to PrEP (only for those with severe impairment).

- other medical condition that would unacceptably increase the risk of harm from study drug or significantly impair the ability to adhere to PrEP.

- Suspected sensitivity or allergy to the study drug or any of its components.

- Currently using an essential product or medication that interacts with the study drug such as the following:

- ART (including nucleoside analogs, non-nucleoside reverse transcriptase inhibitors, protease inhibitors or investigational antiretroviral agents)

- Agents with known nephrotoxic potential:

- aminoglycoside antibiotics (including gentamicin)

- IV amphotericin B

- cidofovir

- cisplatin

- foscarnet

- IV pentamidine

- IV vancomycin

- oral or IV gancyclovir

- other agents with significant nephrotoxic potential

- Drugs that slow renal excretion

- Probenecid

- Immune system modulators

- Systemic chemotherapeutic agents (i.e. cancer treatment medications)

- Ongoing systemic corticosteroids (with the exception of short courses of tapering steroid doses for asthma or other self- limited condition).

- Interleukin-2 (IL-2)

- Interferon (alpha, beta, or gamma)

- Other agent known to have a significant interaction with TDF or FTC

- Proteinuria 2+ or greater by urine dipstick

- Signs or symptoms suggestive of acute HIV infection

- Any other reason or condition that in the opinion of the investigator would interfere with participation, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
SoC + iTab
Text messaging reminders to improve adherence to PrEP

Locations

Country Name City State
United States City of Long Beach Department of Health and Human Services Long Beach California
United States University Southern California Los Angeles California
United States University of California, San Diego San Diego California
United States Harbor-UCLA Medical Center Torrance California

Sponsors (6)

Lead Sponsor Collaborator
University of California, San Diego California HIV/AIDS Research Program, City of Long Beach Department of Health and Human Services, Gilead Sciences, University of California, Los Angeles, University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adherence to PrEP Proportion of participants adherent to PrEP as measured by TFV-DP dried blood spot (DBS) concentrations > 719 fmol/punch at Week 12 and the last on-drug visit. Baseline to Week 48
Secondary Perfect Adherence to PrEP Proportion of participants with perfect adherence to PrEP as measured by TFV-DP dried blood spot (DBS) concentrations > 1246 fmol/punch at Week 12 and the last on-drug visit. Baseline to Week 48
Secondary Rate of HIV Seroconversion Determine the rate of HIV seroconversion in PrEP users and compare the iTAB to SOC arms for number of new infections as a proportion at 48 weeks and end of study. Up to 2.5 years after baseline
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