Reaching for a Cure: HIV and AIDS
HIV Clinical Trials
For further information,
please call Gerry Addison
at
401-793-4979 or
toll free
866-448-7587
|
Anti-HIV Therapy Study
(A5217: TDF+FTC+LPV/r vs. no ART in New Infections)
Drug Dosage Study
(A5175: Once-Daily PI + Non-NRTI Regimens for Initial Tx in Resource-Limited Settings)
Effect of Drug Combinations on Patients Who Have Never Recieved HIV Medications
(A5202: EFV or ATV with RTV combined with FTC/TDF or ABC/3TC in naive subjects)
Overcoming High-level HIV Resistance Study
(A5146: Effect of TDM on Viral Response to Salvage Regimen (NIQ<=1) of 1 or More PIs)
Immediate Versus Deferred Initiation of Drugs Study
(A5164: ART for HIV-Infected Adults with Acute OIs: Immediate vs. Deferred Initiation)
Ezetimibe, HIV and Statin Study
(A5209: Safety, Efficacy,Tolerability of Ezetimibe with Statin for Elevated LDL Cholesterol)
HIV-Patients with Hepatitis C Study
(A5178: Suppressive Long-term Antiviral Management of HCV/HIV Coinfection (SLAM C)
HIV Vaccine Study
(A5197: Antiretroviral Effect MRK Ad5 HIV-1 Gag Vaccine in HIV Individuals Stopping ART)
Anti-HIV Therapy Study
(A5217: TDF+FTC+LPV/r vs. no ART in New Infections)
This study will determine if potent anti-HIV therapy versus no therapy in newly infected patients changes the level of HIV virus when the therapy is discontinued.
Criteria:
- Early HIV-1 infection acquired within the past six months, but beyond acute infection (positive HIV antibody test at screening, but negative test within six months)
- CD4 cell count greater than 350
- HIV viral load greater than 500 copies/ml
- Must be willing to stop treatment after 36 weeks if assigned to the treatment group.
If you are interested in participating, please call 793-4364 or e-mail bhytinen@lifespan.org
Drug Dosage Study
(A5175: Once-Daily PI + Non-NRTI Regimens for Initial Tx in Resource-Limited Settings)
This study will learn if two different once-daily combinations of anti-HIV drugs work as well as the standard twice-a-day combination of anti-HIV drugs for the initial treatment of individuals infected with HIV-1 who are from diverse areas of the world.
Criteria:
- HIV positive
- CD4 cell count less than 300
- Equal to or less than seven days of anti-HIV drugs of HIV therapy at any time before study entry
- Women who have taken single-dose nevirapine or AZT for any period of time during pregnancy to prevent passing on the HIV infection to the child may participate
- Men and women 18 years old or older
If you are interested in participating, please call 793-4396 or e-mail jgormley@lifespan.org
Effect of Drug Combinations on Patients Who Have Never Recieved HIV Medications
(A5202: EFV or ATV with RTV combined with FTC/TDF or ABC/3TC in naive subjects)
This study will learn whether the medication combinations work equally well in patients who have never taken HIV medications before. It will also look at how easy the medications are to take and their side effects.
Criteria:
- HIV viral load 1000 copies/mL or more
- Never taken HIV medications (there are a few exceptions)
- Not already known to be resistant to any HIV medications
If you are interested in participating, please call 793-4771 or hsousa@lifespan.org
Overcoming High-level HIV Resistance Study
(A5146: Effect of TDM on Viral Response to Salvage Regimen (NIQ<=1) of 1 or More PIs)
For people who have failed at least one regimen, this study will determine whether measuring anti-HIV drug levels in the blood and adjusting drug dosages based on these results will overcome high-level HIV resistance. This is called Therapeutic Drug Monitoring (TDM) and may lead to successful suppression of viral load.
Criteria:
- Failed at least one protease inhibitor-containing anti-HIV regimen (currently failing regimen does not have to contain a PI)
- Viral load 1000 copies/mL or more within 90 days
VirtualPhenotyperesult shows resistance to at least one of the tested drugs.
If you are interested in participating, please call 793-4632 or e-mail dperez@lifespan.org
Immediate Versus Deferred Initiation of Drugs Study
(A5164: ART for HIV-Infected Adults with Acute OIs: Immediate vs. Deferred Initiation)
The purpose of the study is to learn whether it is better to start anti-HIV drugs right away, during treatment for the serious infection, or to wait until after the serious infection has been treated. It is not known whether anti-HIV drugs cause side effects that could worsen problems for people with serious infections. Another purpose of the study is to compare the safety and effectiveness of the anti-HIV drugs when started during or after treatment of a serious illness.
Criteria:
- Currently diagnosed with a serious infection (AIDS-related opportunistic infection such as PCP pneumonia, CMV retinitis, or other serious bacterial infection with CD4 cell count less than 200).
- Currently receiving treatment for the serious infection for less than 14 days.
- Have not received any anti-HIV therapy in the past 8 weeks.
- Have not received more than 30 days of anti-HIV therapy in the past 6 months.
- Have not had more than one previous anti-HIV therapy that failed.
If you are interested in participating, please call 793-4632 or e-mail dperez@lifespan.org
Ezetimibe, HIV and Statin Study
(A5209: Safety, Efficacy,Tolerability of Ezetimibe with Statin for Elevated LDL Cholesterol)
The purpose of this study is to learn how safe and how well tolerated it is to take Ezetimibe (Zetia) in combination with HIV and statin medications in people who are HIV infected. In addition, the study will learn how well it works to lower LDL cholesterol.
Criteria:
- Must have taken statin and anti-HIV medications for at least the 3 months before entering study, and have had no changes in the way they are taken for at least 30 days
- Must be on a diet and exercise program to help lower cholesterol for at least 30 days before entering study, and be willing to stay on this while on study
- Fasting blood work that shows an LDL cholesterol greater than or equal to 130
- No history of diabetes mellitus, coronary heart disease, or congestive heart failure
- Cannot have taken ezetimibe in the past
If you are interested in participating, please call 793-4971 or e-mail ppoethke@lifespan.org
HIV-Patients with Hepatitis C Study
(A5178: Suppressive Long-term Antiviral Management of HCV/HIV Coinfection (SLAM C)
The study is to determine whether long-term treatment with PEG-IFN slows the rate of liver damage caused by hepatitis C virus (HCV) in people co-infected with HCV and HIV for whom other treatment failed to clear the HCV.
Criteria:
- Hepatitis C and HIV co-infection
- Currently on stable antiretroviral therapy for at least 8 weeks, have not received therapy at least 4 weeks prior to entry, OR on no antiretroviral therapy prior to entry and no plans to start therapy for 24 weeks after entry
- HIV-1 RNA less than 50,000 copies/mL
- CD4 count greater than 200 cells/mm3
- No evidence of severe liver disease based on liver biopsy done within 2 years
Step 1 Eligibility: Never treated for HCV OR previously taken at least 12 weeks of IFN, IFN + ribavirin, PEG-IFN, or PEC-IFN + ribavirin. Has not cleared the HCV. No HCV treatment in the past 4 weeks.
Step 2 Eligibility: Currently taking PEG-IFN + ribavirin for 12 - 18 weeks, tolerating medications. Has not cleared the HCV.
If you are interested in participating, please call 793-4364 or e-mail bhytinen@lifespan.org
HIV Vaccine Study
(A5197: Antiretroviral Effect MRK Ad5 HIV-1 Gag Vaccine in HIV Individuals Stopping ART)
This study will compare the HIV viral load of people off anti-HIV drugs who have either received an HIV-1 vaccine (MRK Ad4) or a vaccine placebo. Longer term safety information about the HIV-1 vaccine will also be collected.
Criteria:
- On a stable medication regimen for at least 4 weeks.
- Must have been on anti-HIV medications that have suppressed the virus for at least two years. Good documentation of this suppression is required.
- Viral load must now be less than 50 copies/ml.
- CD4 cell count greater than 500.
- Must have an ad5 neutralizing titer of less than 200 at screening - this will be drawn and determined by the study.
- Must be willing to undergo a treatment interruption
If you are interested in participating, please call 793-4971 or e-mail ppoethke@lifespan.org
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