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For Information about the Merck Vaccine Failure, click here: http://www.stepstudies.com
For Information about the Step Study Results, click here: http://www.hvtn.org
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Clinical Trials
Current Open Clinical Trials
HIV-Associated Diarrhea Study: ADVENT Trial
This is a 24-week Phase 3, randomized, double-blind, placebo-controlled study to assess the
efficacy and safety of three doses of crofelemer, a natural compound. Eligible volunteers will
be randomized to receive crofelemer or placebo administered orally twice daily for the initial
placebo-controlled treatment phase; thereafter for 20 weeks all participants will receive
crofelemer. Participants will be compensated for their time and inconvenience for up to $400.
Basic Study Requirements:
- Male or female aged 18 years or older
- HIV-1 infection confirmed by standard serological tests and/or viral load
- History of diarrhea of at least 1 month's duration
Vicriviroc Study: For antiretroviral-experienced HIV-1-positive volunteers
This is a 48-week, Phase 3, randomized, double-blinded, placebo-controlled study evaluating the effects
of vicriviroc in combination with an optimized background regimen. The investigational drug, vicriviroc,
inhibits entry of HIV into cells and is active against a variety of HIV strains, including antiretroviral-resistant
strains. Eligible volunteers will be randomized in a 2:1 ratio to receive vicriviroc or placebo for 48 weeks. Participants
will be compensated for their time and inconvenience.
Basic Study Requirements
- HIV-1-positive adult at least 18 years of age
- Viral load greater than 1,000 copies/ml
- Must be antiretroviral-experienced
If vicriviroc at the dosage studied proves to be safe and effective, study volunteers who successfully complete
48 weeks of treatment and for whom it is medically appropriate will be offered vicriviroc free of charge until the drug
is commercially available. Volunteers will not be compensated for this part of the study.
Natural Therapy Study: POM Study
This is a 10-week Phase 2/3 proof-of-concept, randomized, double-blinded, placebo-controlled study to evaluate the
effects of Punica granatum (pomegranate) juice on the indices of quality of life and cardiac health in
HIV-1-positive volunteers. Eligible volunteers will be randomized in a 1:1:1 ratio to receive one of two formulations
of pomegranate juice (once daily, 8-ounce) or a placebo. Volunteers who complete participation in the 10 week study
and were in the placebo group will be re-randomized to receive one of two pomegranate juice formulations for another
8-weeks. Volunteers will be compensated $25 per visit for their time and inconvenience..
Basic Study Requirements
- HIV-1-positive adult at least 18 years of age
- CD4 cell count greater than 350 cells/mm 3
- Treatment naïve or not currently on antiretroviral therapy for at least 90 days prior to the screening visit
- No current use of immune modulating therapies (i.e., IL-2, vaccine, Interferon gamma)
U19 - Anorectal Microbicide Project
This study will help researchers to develop a rectal microbicide, a new HIV prevention strategy to be used during
anal intercourse. This one visit study involves a computer-assisted interview focusing on the behaviors surrounding
receptive anal intercourse, an anorectal examination, along with testing for sexually transmitted infections in compliance
with local, state, and federal laws regarding sexually transmitted diseases. This study does not involve any medication or
experimental procedures. Volunteers will be compensated $100 for one completed study visit for their time and inconvenience.
Basic Study Requirements
- Males or females at least 18 years of age
- HIV-negative or HIV-positive
- Either practices or does not practice receptive anal intercourse
Detecting HIV Genotypic Drug Resistance: HIV SpectraPoint
Detecting HIV Genotypic Drug Resistance: HIV SpectraPoint
This is a Phase 1 pilot, proof-of-concept study to determine the efficacy of an in vitro diagnostic device, HIV
SpectraPoint , in HIV-positive patients with prior resistance to antiretroviral medications. The primary objective of
this study will compare the ability of SpectraPoint resistance technology to standard genotypic assay. This study requires
one clinic visit with one blood draw. Volunteers may optionally return and discuss their resistance results with AIDS Research Alliance
staff. Volunteers will be compensated $50 for their time and inconvenience.
Basic Study Requirements:
- Male or female volunteers aged 18 years or older
- HIV-1-positive with a viral load greater than 500 copies/ml
- Currently on antiretroviral therapy
- No current Hepatitis B infection
If you are interested in any of these studies, please call AIDS Research Alliance at (310) 358-2429, preferably after 1:30 pm.
Additional Research & Clinical Trials at ARA |
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STUDY & INDICATION |
DESCRIPTION |
STATUS |
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Pre-Clinical &
Basic Research
AIDS Research Alliance (ARA) |
ARA is engaged in a number of ongoing preclinical
and basic research projects. For example, the prostratin
update (page 24) outlines important progress in
the development of prostratin as an anti-HIV drug targeting
viral reservoirs. |
Study Ongoing |
New Investigational
Anti-HIV drug
Investigational
Integrase Inhibitor
Major Pharmaceutical Co. |
This study compares the safety and activity of an investigational
integrase inhibitor in combination regimens
with optimized background treatments, compared to
optimized background therapy alone in antiretroviral experienced,
HIV-infected volunteers with documented
resistance to one of the antiretroviral drug in each class. |
Enrollment &
Study Ongoing |
New Investigational
Protease Inhibitor
TMC114
Tibotec |
This study compares the efficacy, safety and tolerability
of TMC114/RTV versus LPV/RTV in treatmentexperienced
HIV-1 infected volunteers. |
Enrollment &
Study Ongoing |
New Investigational
Treatment for
HIV-Associated
Neuropathic Pain
Pregabalin A0081066
Pfizer |
This trial investigates the efficacy and safety of pregabalin
(versus placebo) in the treatment of neuropathic
pain in HIV-positive volunteers. |
Enrollment &
Study Ongoing |
New Investigational
Treatment to
Decrease Abdominal
Fat Accumulation
TH9507 (Growth Hormone Analog)
Theratechnologies Inc. |
This study assesses the efficacy and safety of
TH9507, a growth hormone releasing factor analog
in HIV-positive volunteers with excess abdominal
fat accumulation. |
Enrollment &
Study Ongoing |
New Investigational
Test To Measure
Resistance to Anti-HIV
Medications
HIV SpectraPoint
SpectraDigital Corporation |
This Phase I study investigates the efficacy of an
in vitro diagnostic device, HIV SpectraPoint, in HIV -
positive volunteers with prior resistance to antiretroviral
medications. |
Enrollment &
Study Ongoing |
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STUDY & INDICATION |
DESCRIPTION |
STATUS |
Investigational
Supplement for
treatment of Diarrhea
Microbial Food Supplement
AIDS Research Alliance (ARA) |
This study investigates the safety and efficacy of
Bifidobacterium infantis therapy in the treatment of
HIV-1 associated diarrhea. |
Enrollment &
Study Ongoing |
Investigational
HIV-1 Vaccine
Major Pharmaceutical Co. |
This study investigates the safety, tolerability and efficacy
of an investigational HIV-1 vaccine in healthy volunteers
at higher risk of HIV infection. |
Enrollment &
Study Ongoing |
Investigational
HIV-1 Vaccine
Major Pharmaceutical Co. |
This study investigates the safety, tolerability and efficacy
of an investigational HIV-1 vaccine in healthy volunteers
at low risk of HIV infection. |
Enrollment &
Study Ongoing |
New Investigational
Regimen for
HIV-Positive Volunteers
Failing HAARTContaining
Regimen
BMS AI424128
Bristol-Myers Squibb |
This study evaluates 150L substitution among treatment-
experienced HIV-positive volunteers who have
failed Highly Active Antiretroviral Therapy (HAART)
regimens containing Atazanavir (ATV). |
Enrollment &
Study Ongoing |
New Investigational
Anti-HIV Medication
CCR5
Human Genome Sciences, Inc. |
This study evaluates the safety, tolerability, pharmacokinetics,
and pharmacodynamics of CCR5mAb004
(human monoclonal IgG4 antibody to CCR5) in HIV-
1 positive individuals who are not receiving antiretroviral
therapy. |
Enrollment
Pending |
New Investigational
Anti-HIV Medication
Investigational
Integrase Inhibitor
Major Pharmaceutical Co. |
This study compares the safety and activity of an
investigational integrase inhibitor in combination regimens
with two approved antiviral drugs, compared to
a standard 3 drugs combination in antiretroviralnaïve,
HIV-infected volunteers. |
Enrollment
Complete &
Study Ongoing |
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