Safety, Efficacy and Psychological Effects of Treating Antiretroviral Drug-Induced Facial Lipoatr… (NCT00333684) | Clinical Trial Compass
CompletedPhase 2
Safety, Efficacy and Psychological Effects of Treating Antiretroviral Drug-Induced Facial Lipoatrophy With Bio-Alcamid
Canada36 participantsStarted 2004-12
Plain-language summary
Evaluate and record any changes in the Quality of Life and psychological state of the affected study group following treatment with Bio-Alcamid.
Evaluate the safety and efficacy of Bio-Alcamid for restoring the natural fullness and contours of the face affected by HIV drug-induced lipoatrophy. Pre-treatment classification and post treatment recording of changes will be performed by, both, the Principal Investigator and the Treatment Specialist and independently by a 'Blinded' Co-Investigator at post treatment Week 12.
Safety data for Bio-Alcamid will be collected throughout the duration of the study. Safety will be determined by the rates of procedure-related events and adverse experiences associated with the use of Bio-Alcamid.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have moderate to severe levels of facial lipoatrophy determined by the three investigstors
* If female of child-bearing potential (not menopausal for at least 1 year nor surgically sterile), have a negative urine pregnancy test prior to any study treatments and be willing to use oral contraception or another medically acceptable form of contraception for the duration of the study
* Be able to understand and comply with the requirements of this study
* Be willing and able to provide written Informed Consent prior to any study-related procedures being performed
* Agree to refrain from seeking other treatment for lipoatrophy in the facial area while participating in this study
Exclusion Criteria:
* Are pregnant, lactating, or trying to become pregnant
* Had prior therapy (e.g., other permanent or biodegradable injectable fillers or surgical correction such as a face-lift, etc.) within 9 months prior to entry into the study or are planning to undergo such therapy during the study
* Have any active inflammation, infection, or unhealed wound of the face
* Have any contraindicated condition described in the package insert for the product to be administered.
* Have a history of anaphylaxis or multiple severe allergies.
* Have planned relocation during the study, which would make follow-up visits impossible during the course of the study
* Used aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 week prior to initial or touch-up treatment or are …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate Quality of Life using the slightly modified Dermatology Quality Life Survey and the MOS-HIV Survey.
Timeframe: 96 weeks
Trial details
NCT IDNCT00333684
SponsorCanadian Immunodeficiency Research Collaborative