HIV Clinical Trials &
AIDS Clinical Trials
HIV clinical trials and AIDS clinical trials are constantly underway since finding a cure for this illness that has now become a worldwide epidemic is of the utmost importance. From trying to find a vaccine to researching new, better and more effective medications to treat the condition. HIV clinical trials vary in focus, duration and final objective and below I have listed a number of these studies that are currently going on. There are some benefits to participating in these trials and they include:
- Gaining access to new treatments and treatments without charge
- Since most of these trials are conducted by experts in the field, you will have access to care from these top-notch physicians and healthcare professionals
- Last, but certainly not the least, your contribution to this research will help many other people the world over
Of course I must also mention that as with most clinical trials there may be some risks involved if/when you choose to participate in these AIDS clinical trials. - Because you will sometimes be using new medications, their effectiveness may not yet be established and it is quite possible that they may not be of any medical benefit, or worse, may be harmful
- Clinical trials are also where medication side effects are established so you may experience these
- Some studies are very time-intensive and may require frequent visits so be prepared to flexible with your time and able to travel/drive back and forth to your study site
Here is a random sampling of some on-going HIV clinical trials:
Anti-HIV Medications for People Recently Infected With HIV
Description: Some doctors favor starting anti-HIV treatment as soon as possible after patients are confirmed to be infected however there is no evidence to show whether or not this helps to slow the progression of the disease. The aim of this study is to compare outcomes between people who start treatment right away and those who don't. So some people in this study will receive treatment and others won't.Estimated completion date: August 2011 Inclusion Criteria: - Recently diagnosed (within the last 12 months) with HIV infection
- Have not taken any medications to treat HIV/AIDS (though in some cases some people who have may still be acceptedint o the study)
- Able to swallow tablets or capsules
- Must be willing to use acceptable forms of contraception
Exclusion Criteria:- CD4 count and viral load below a pre-determined threshold
- People on chemotherapy, anti-HIV medications, other investigational medications, etc. within 30 days of starting the study
- Serious illness requiring hospitalization; involutary incarceration
- Current alcohol or drug use that the investigator feels may interfere with the study
- Pregnant or breastfeeding women
Gender: Both Ages: 18 years and above Locations and contacts: - Johns Hopkins University, Baltimore, Maryland - Linda G. Apuzzo, BS/CCRC 410-614-7796 lapuzzo@jhsph.edu
- University of British Columbia, Vancouver, British Columbia, Canada - Jennie Prasad, MS 604-642-6429 jenniepd@interchange.ubc.ca
- Sunnybrook Health Sciences Center, Toronto, Ontario, Canada - Miriam Bast 416-480-5900 mriam.bast@ssunnybrook.ca
- Canadian Immunodeficiency Research Collaborative (CIRC) Inc - Mona Loutify, MD 416-465-7936 loutify@schospital.ca
- CHUM-Hotel-Dieu - Genevieve Bujold 514-890-9000 genevieve.bujold.chum@ssss.gouv.qc.ca
In addition to the more general types of HIV clinical trials, there are also some that are restricted to certain population groups. These are particularly useful in determining whether a particular type of treatment is more effective in one group of people than another and can help plan more effective treatment strategies. An example of this type of HIV clinical trial is as follows.
Raltegravir as Early Therapy in African-Americans Living With HIV Study (REAL)
Description: The purpose of this study is examine the safety and efficacy (among other things), of Isentress (Raltegravir) in African-American men and women.Estimated completion date: July 2010 Inclusion criteria: - Documented HIV-1 infection
- Patients describe themselves as (consider themselves to be) African-American
- Have received less than 7 days total of previous HIV therapy
- Plasma HIV RNA PCR equal to or greater than 1000 copies/mL within 90 days prior to study entry
- Can provide informed consent and is able to comply with study medication and procedures
- ALT (SGPT) < or equal to 3.0 x ULN within 45 days prior to study entry
- GRF > 60 as calculated by MDRD within 45 days prior to study entry
- Non-pregnant women; must have a negative pregnancy test within 48 hours before entry into the study. Must also agree not to get pregnant during the study and to use a reliable method of contraception
Exclusion criteria: - Pregnancy
- Breastfeeding
- Prior use of Isentress (Raltegravir)
- Receiving any vaccination within 30 days of entry into the study
- Any condition which in the opinion of the investigator is likely to interfere with follow-up or ability to take the study medication appropriately
Gender: Both Ages: 18 years and above Contacts: - David Ragan, RN 919-966-2623 davidrag@med.unc.edu
- Donna Pittard, RN 919-843-6512 donna_pittard@med.unc.edu
Sometimes, HIV clinical trials are conducted to find more uses or use populations for a drug that has already been approved. Most studies exclude children initially and then later conduct studies specifically to test the drug in children. These studies are usually conducted by the drug manufacturers themselves. Here is one such ongoing study.
An Expanded Access Study of Oral Liquid Efavirenz in the
Treatment of Children With HIV Infection
Description: This study is being done to assess how safe and tolerable a liquid solution of Sustiva (Efavirenz) is in children between the ages of 3 and 16 who have either never received any HIV treatment or who are not tolerating or not responding to treatment using another anti-HIV drug AND who are not able to swallow Sustiva capsules.Estimated completion date: December 2010 Inclusion criteria: - Children 3-16 years old
- May or may not have used anti-HIV medication(s)
- Not responding to or not tolerating current anti-HIV medication(s)
- Limited number of other viable options
- Unable to take tablets or capsules
Exclusion criteria: - Weight under 10kg (22lbs)
- Failure on or concomitant use of other NNRTIs
- Has an active opportunistic infection or disease
- Has had more than two episodes of moderate to severe diarrhea or vomiting lasting more than four days within the past three months
Gender: Both Ages: 3 - 16 years old Contact: This study is being conducted/sponsored by the drug manufacturer of Sustiva - Bristol-Myers Squibb. Contact them for this study at Clinical.Trials@bms.com
Please note that there are constantly many trials going on and the above are just a very small sampling of them all. I will try to keep this page updated with more that I think may be of interest to users of this site as time goes by.
The tongue ever turns
to the aching tooth
Source of ongoing HIV clinical trials information comes from ClinicalTrials.gov (NOTE: opens in a new window)
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April 28, 2009
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