7 ms·

How do tests for drugs like this get conducted? "Here's a shot, go have sex with people with HIV"? I hope the young women conducting the trials were compensate

How do tests for drugs like this get conducted? "Here's a shot, go have sex with people with HIV"? I hope the young women conducting the trials were compensated sufficiently for the risk taken, especially those who contracted HIV during the period.

mmh0000 2y ago
You give the shot to a group and you give no shot to another group. Then you compare rates of HIV contractions between the two groups.
- tupshin 2y ago
  The summary text explicitly called out why that would be unethical in this case.
  - j0hngalt 2y ago
    [dead]
  - asveikau 2y ago
    They don't ask people to live their lives any differently than they would, nor do they expose anyone to HIV on purpose; they just track them assuming that x% of people get HIV in any given year. So they compare what X is for people who got the shot, vs those who did not. As I skim TFA, they say nobody who got the shot ended up getting HIV, which would be statistical anomaly for the population they tested.
    - smeej 2y ago
      It's not "no shot," though. It's other existing, widely available forms of pre-exposure prophylaxis. They're not comparing the new treatment to nothing. They're comparing it to existing treatments.
      - asveikau 2y ago
        Oh, ok, I skimmed past this: > The shot was also superior to once-daily Truvada, another Gilead drug that is used for HIV prevention. That's good news. As I understand it the existing treatments were already very good. And these injections are only once per year.
        deleted 2y ago
        [deleted]
        duskwuff 2y ago
        Twice a year, but yes. That's a huge benefit -- not only is it easier for patients to stay on the treatment, but it's likely to be a lot cheaper as well.
        smeej 2y ago
        I wonder how much variation there might be in terms of margin of error. Like, how close do they have to get to keeping people on a rigid 6-month schedule? Would 7 be fine? For what percentage of people? I'm assuming they have reason to believe once a year isn't enough, so that's an upper bound, but what's the lower one?
        adgjlsfhk1 2y ago
        the short answer is no one knows (yet). if/once it gets approval, there likely would be a followup study on how much you can stretch the timing (possibly with dosage variation)
        duskwuff 2y ago
        > I wonder how much variation there might be in terms of margin of error. Probably quite a bit. The trial used the same dose of lenacapavir as what's used for maintenance in HIV patients; it's quite possible that less is needed to prevent infection in a healthy patient. Unfortunately, there's really no safe/ethical way for them to test lower doses.
        2y ago
jghn 2y ago
They're comparing against typical rates of infection over time.
Svoka 2y ago
How does your mind even go there? Did you consider they just give shots and see how many of treated got infected in treatment vs control group?
- nevi-me 2y ago
  People are sexually active at different rates over different times, I also assume that a 100 people having sex with each other, where none of them have HIV, would not contract it. It's like giving police officers new buller-proof vests, and then none of them getting in the firing line. You can't say that your vests are more efficient than other vests if they technically didn't get tested. So, my thinking was how they ensure that all test groups are sexually exposed to other people with HIV, for the trial to be effective.
  - opprobium 2y ago
    South Africa (study was in SA and Uganda) has an adult HIV prevalence of 18.3% and 210k new infections per year. It is easy to select a high risk group in which you would expect to see new HIV infections during the course of the study without intervention.
  - imzadi 2y ago
    They don't need to ensure that all test groups are exposed to people with HIV. There is already a known risk factor for the specific population. All they need to do is see if the people who received the medication had more/fewer/similar infection rates as those who didn't. Think about it like studies on which cars perform better in crashes. They don't need to have people drive more wrecklessly to determine if the car is safer. They just need to look at the expected risk compared to the outcomes of the people who drive that car. They are already doing the risky thing.
  - loeg 2y ago
    > So, my thinking was how they ensure that all test groups are sexually exposed to other people with HIV, for the trial to be effective. They don't. Some people will organically have sex with people with HIV, and some will not. Your study just needs to recruit enough participants that it is likely some will. Your study absolutely does not tell people to deliberately have sex with HIV+ partners.
dekhn 2y ago
Here's the study page. https://www.purposestudies.com/purpose1/ https://www.purposestudies.com/purpose1/ and extensive details on clinicaltrials.gov https://clinicaltrials.gov/study/NCT04994509 https://clinicaltrials.gov/study/NCT04994509 It's double-blind so the patients do not know if they received the drug or an alternative. The investigators inform the patients of the risk and tell them to do what they would usually do. The participants must meet certain criteria including already being sexually active. The investigators would not tell the participants to be more sexually active, or active with more risky people than they normally would. The prevalence of HIV infection in the area is already fairly high so people are actively at risk already. I believe there was only very limited compensation.
withinrafael 2y ago
I didn't think the question was unreasonable as some suggest and couldn't find an answer in any of the replies to you. Poking around, it's my understanding that double blind procedure only covers treatment allocation--that is, who gets the placebo or not--and does not exclude general experiment communication to patients. I imagine trial communication is something generic along the lines of "We're running a novel drug trial, help us gather more data for $50/shot."
- deleted 2y ago
  [deleted]
- hkgjjgjfjfjfjf 2y ago
  [dead]
- bee_rider 2y ago
  I don’t think the question is inherently unreasonable, but they asked it in a really flip and disrespectful way, and weirdly went with a very negative assumption. There’s also a whole field of medical research ethics and, I guess, it is hard to believe that somebody could be not aware of that (then again, I guess everyone has to learn it at some point).
  - nevi-me 2y ago
    Yeah, I asked it in a negative way, probably because I hold the view that Africa is the dumping ground for unethical behaviour/products. Just 2 months ago we were outraged at Nestle putting sugar in baby foods [0] in Africa. We have 2 kids, the eldest of which is addicted to sugar. As a South African, I appreciate that we're also the most unequal country in the world (by Gini coef). So, some of what was going on in my mind as I read the Bloomberg piece, was: * did they choose people at random, because the high HIV rate is obviously skewed towards vulnerable groups (think a young woman who's financially dependent on her boyfriend, who has multiple partners) * just because the HIV rate is prevalent, doesn't mean that young sexually active people would have multiple partners, so how do they account for situations where we were sexually active, but with 1 or safe partners * condoms are freely available in clinics and often public toilets, and we've generally gone past the fear of asking for them. So how does safe sex affect their study [0] https://www.wits.ac.za/news/latest-news/opinion/2024/2024-04/sugar-in-baby-food-why-nestle-needs-to-be-held-to-account-in-africa.html#:~:text=As%20the%20Public%20Eye%20investigation,the%20same%20product%20has%20none https://www.wits.ac.za/news/latest-news/opinion/2024/2024-04....
3523582908 2y ago
A while ago I watched this highly disturbing documentary produced by Vice about the prevalence of rape in the DRC as a weapon of war and terror against women. [1]. I have to imagine that this is involved, somehow. 1: https://www.youtube.com/watch?v=-IffpoUQpDc&pp=ygUUdGhlIHZpY2UgY29uZ28gd29tZW4%3D https://www.youtube.com/watch?v=-IffpoUQpDc&pp=ygUUdGhlIHZpY...
- folli 2y ago
  How so?
- JumpCrisscross 2y ago
  > the prevalence of rape in the DRC This was in South Africa. You might as conclude on life in America based on observations in Caracas.
  - samatman 2y ago
    https://www.amnestyusa.org/updates/one-in-four-men-admits-to-rape-in-south-africa/ https://www.amnestyusa.org/updates/one-in-four-men-admits-to... This is explicitly referred to as a risk factor in the study, although they say "gender-based violence"
asveikau 2y ago
As I understand it would go like this: Normally, some percentage of the population will get HIV in any given year. So what you do is give a bunch of people the shot and track them long term. You count how many got HIV after N years, compared to what would be expected in a normal population. Nobody is exposed to HIV as part of the study, that exposure would come through the participants living their ordinary lives.
- deleted 2y ago
  [deleted]
- pitaj 2y ago
  Close, but it's actually run with two large groups: one that gets the real shot, and one that gets a fake shot. You then compare the two groups, rather than comparing with the population.
  - spencerchubb 2y ago
    That would be extremely unethical, exposing the control group to needless risk. There is already another drug that helps prevent hiv, it's called truvada. They tested this new one against truvada, and basically learned it's a lot more effective.
    - Dylan16807 2y ago
      Ridiculous. As long as most people are taking no preventatives, it is not "extremely unethical" to have the control group also take no preventatives.
      - kjhcvkek77 2y ago
        Who would sign up for your study? The diligent person already on truvada - would they risk getting placebo? No. Or the person too careless to take truvada? Would they go to the trouble of participating in a study for a 50% chance of protection? No.

mmh0000 2y ago

You give the shot to a group and you give no shot to another group. Then you compare rates of HIV contractions between the two groups.

tupshin 2y ago
The summary text explicitly called out why that would be unethical in this case.
- j0hngalt 2y ago
  [dead]
- asveikau 2y ago
  They don't ask people to live their lives any differently than they would, nor do they expose anyone to HIV on purpose; they just track them assuming that x% of people get HIV in any given year. So they compare what X is for people who got the shot, vs those who did not. As I skim TFA, they say nobody who got the shot ended up getting HIV, which would be statistical anomaly for the population they tested.
  - smeej 2y ago
    It's not "no shot," though. It's other existing, widely available forms of pre-exposure prophylaxis. They're not comparing the new treatment to nothing. They're comparing it to existing treatments.
    - asveikau 2y ago
      Oh, ok, I skimmed past this: > The shot was also superior to once-daily Truvada, another Gilead drug that is used for HIV prevention. That's good news. As I understand it the existing treatments were already very good. And these injections are only once per year.
      - deleted 2y ago
        [deleted]
      - duskwuff 2y ago
        Twice a year, but yes. That's a huge benefit -- not only is it easier for patients to stay on the treatment, but it's likely to be a lot cheaper as well.
        smeej 2y ago
        I wonder how much variation there might be in terms of margin of error. Like, how close do they have to get to keeping people on a rigid 6-month schedule? Would 7 be fine? For what percentage of people? I'm assuming they have reason to believe once a year isn't enough, so that's an upper bound, but what's the lower one?
        adgjlsfhk1 2y ago
        the short answer is no one knows (yet). if/once it gets approval, there likely would be a followup study on how much you can stretch the timing (possibly with dosage variation)
        duskwuff 2y ago
        > I wonder how much variation there might be in terms of margin of error. Probably quite a bit. The trial used the same dose of lenacapavir as what's used for maintenance in HIV patients; it's quite possible that less is needed to prevent infection in a healthy patient. Unfortunately, there's really no safe/ethical way for them to test lower doses.
        2y ago

jghn 2y ago

They're comparing against typical rates of infection over time.

Svoka 2y ago

How does your mind even go there? Did you consider they just give shots and see how many of treated got infected in treatment vs control group?

nevi-me 2y ago
People are sexually active at different rates over different times, I also assume that a 100 people having sex with each other, where none of them have HIV, would not contract it. It's like giving police officers new buller-proof vests, and then none of them getting in the firing line. You can't say that your vests are more efficient than other vests if they technically didn't get tested. So, my thinking was how they ensure that all test groups are sexually exposed to other people with HIV, for the trial to be effective.
- opprobium 2y ago
  South Africa (study was in SA and Uganda) has an adult HIV prevalence of 18.3% and 210k new infections per year. It is easy to select a high risk group in which you would expect to see new HIV infections during the course of the study without intervention.
- imzadi 2y ago
  They don't need to ensure that all test groups are exposed to people with HIV. There is already a known risk factor for the specific population. All they need to do is see if the people who received the medication had more/fewer/similar infection rates as those who didn't. Think about it like studies on which cars perform better in crashes. They don't need to have people drive more wrecklessly to determine if the car is safer. They just need to look at the expected risk compared to the outcomes of the people who drive that car. They are already doing the risky thing.
- loeg 2y ago
  > So, my thinking was how they ensure that all test groups are sexually exposed to other people with HIV, for the trial to be effective. They don't. Some people will organically have sex with people with HIV, and some will not. Your study just needs to recruit enough participants that it is likely some will. Your study absolutely does not tell people to deliberately have sex with HIV+ partners.

dekhn 2y ago

Here's the study page. https://www.purposestudies.com/purpose1/ https://www.purposestudies.com/purpose1/ and extensive details on clinicaltrials.gov https://clinicaltrials.gov/study/NCT04994509 https://clinicaltrials.gov/study/NCT04994509 It's double-blind so the patients do not know if they received the drug or an alternative. The investigators inform the patients of the risk and tell them to do what they would usually do. The participants must meet certain criteria including already being sexually active. The investigators would not tell the participants to be more sexually active, or active with more risky people than they normally would. The prevalence of HIV infection in the area is already fairly high so people are actively at risk already. I believe there was only very limited compensation.

withinrafael 2y ago

I didn't think the question was unreasonable as some suggest and couldn't find an answer in any of the replies to you. Poking around, it's my understanding that double blind procedure only covers treatment allocation--that is, who gets the placebo or not--and does not exclude general experiment communication to patients. I imagine trial communication is something generic along the lines of "We're running a novel drug trial, help us gather more data for $50/shot."

deleted 2y ago
[deleted]
hkgjjgjfjfjfjf 2y ago
[dead]
bee_rider 2y ago
I don’t think the question is inherently unreasonable, but they asked it in a really flip and disrespectful way, and weirdly went with a very negative assumption. There’s also a whole field of medical research ethics and, I guess, it is hard to believe that somebody could be not aware of that (then again, I guess everyone has to learn it at some point).
- nevi-me 2y ago
  Yeah, I asked it in a negative way, probably because I hold the view that Africa is the dumping ground for unethical behaviour/products. Just 2 months ago we were outraged at Nestle putting sugar in baby foods [0] in Africa. We have 2 kids, the eldest of which is addicted to sugar. As a South African, I appreciate that we're also the most unequal country in the world (by Gini coef). So, some of what was going on in my mind as I read the Bloomberg piece, was: * did they choose people at random, because the high HIV rate is obviously skewed towards vulnerable groups (think a young woman who's financially dependent on her boyfriend, who has multiple partners) * just because the HIV rate is prevalent, doesn't mean that young sexually active people would have multiple partners, so how do they account for situations where we were sexually active, but with 1 or safe partners * condoms are freely available in clinics and often public toilets, and we've generally gone past the fear of asking for them. So how does safe sex affect their study [0] https://www.wits.ac.za/news/latest-news/opinion/2024/2024-04/sugar-in-baby-food-why-nestle-needs-to-be-held-to-account-in-africa.html#:~:text=As%20the%20Public%20Eye%20investigation,the%20same%20product%20has%20none https://www.wits.ac.za/news/latest-news/opinion/2024/2024-04....

3523582908 2y ago

A while ago I watched this highly disturbing documentary produced by Vice about the prevalence of rape in the DRC as a weapon of war and terror against women. [1]. I have to imagine that this is involved, somehow. 1: https://www.youtube.com/watch?v=-IffpoUQpDc&pp=ygUUdGhlIHZpY2UgY29uZ28gd29tZW4%3D https://www.youtube.com/watch?v=-IffpoUQpDc&pp=ygUUdGhlIHZpY...

folli 2y ago
How so?
JumpCrisscross 2y ago
> the prevalence of rape in the DRC This was in South Africa. You might as conclude on life in America based on observations in Caracas.
- samatman 2y ago
  https://www.amnestyusa.org/updates/one-in-four-men-admits-to-rape-in-south-africa/ https://www.amnestyusa.org/updates/one-in-four-men-admits-to... This is explicitly referred to as a risk factor in the study, although they say "gender-based violence"

asveikau 2y ago

As I understand it would go like this: Normally, some percentage of the population will get HIV in any given year. So what you do is give a bunch of people the shot and track them long term. You count how many got HIV after N years, compared to what would be expected in a normal population. Nobody is exposed to HIV as part of the study, that exposure would come through the participants living their ordinary lives.

deleted 2y ago
[deleted]
pitaj 2y ago
Close, but it's actually run with two large groups: one that gets the real shot, and one that gets a fake shot. You then compare the two groups, rather than comparing with the population.
- spencerchubb 2y ago
  That would be extremely unethical, exposing the control group to needless risk. There is already another drug that helps prevent hiv, it's called truvada. They tested this new one against truvada, and basically learned it's a lot more effective.
  - Dylan16807 2y ago
    Ridiculous. As long as most people are taking no preventatives, it is not "extremely unethical" to have the control group also take no preventatives.
    - kjhcvkek77 2y ago
      Who would sign up for your study? The diligent person already on truvada - would they risk getting placebo? No. Or the person too careless to take truvada? Would they go to the trouble of participating in a study for a 50% chance of protection? No.