Studies for people who have never taken medicines to treat HIV

ACTG 5232: 

This is a small study investigating the extent of immune defects in people who have Hepatitis C, HIV, or have both HIV and Hepatitis C. This will be done by giving a tetanus booster shot and Hepatitis A & B vaccine to people who have never had hepatitis A and/or B and seeing how well they respond.  To be eligible for this study, you must have never had hepatitis A or B infection nor received the vaccine for either of these two viral infections.  Additionally, participants must fit into one of these three categories:  Arm A: Have hepatitis C viral infection that does not need current treatment and be HIV negative; Arm B: Have HIV infection that does not require treatment and be hepatitis C negative; or
Arm C: Have both HIV and hepatitis C infection, but neither disease requires active treatment.  Participants will be in the study for 24-weeks.

AIN 503 / ACTG 5217:

This 96-week study will evaluate the safety and effectiveness of treating early HIV infection or not.  Participants will either receive emtricitabine, tenofovir, and Kaletra for 36 weeks or no medications.  Volunteers must have a diagnosis of HIV within 6 months of study entry, have had no prior anti-HIV treatment, and have a CD4 > 350 and viral load > 500.  Study medications are provided.

Studies for people who need a new HIV treatment

ACTG 5241:

This 60-week study will look at whether newer anti-HIV drugs are safe and effective in people whose current HIV medicines are not working. The study will also test whether using a specific type of medicines called nucleoside reverse transcriptase inhibitors (NRTIs) are needed to treat HIV in persons failing their current medicines.  Finally this study will test whether a medicine resistance test score called the cPSS is able to predict which drugs will work best in people whose virus is resistant to specific HIV medications.  To enter the study, you must have HIV viral load greater than 1000, currently on an HIV drug regimen that includes a protease inhibitor, have resistance to multiple types of HIV medications.  All study medications except NRTIs and ritonavir are provided.

Studies to treat the complications of HIV

ACTG 5212:

This study is for participants who have a viral load of less than 200 but continue to have a low CD4 cell count (less than 200).  The study will use the drug, palifermin, to see if it is effective in increasing CD4 counts.  Palifermin is currently approved in treating mouth sores in cancer patients, but has not been approved by the U. S. Food and Drug Administration for the treatment of HIV.  Participants must be receiving their current anti-HIV regimen for at least 6 months and no plans to change their medication regimen and cannot have allergies to E-coli derived medications.  The study requires 3 consecutive days of study drug through IV injection. Compensation for some study procedures during this 24-week trial.

Observational Studies:

ACTG 5128:

Participants of this study must be a current or past participant in an ACTG study and agree to have a one-time blood draw.  Volunteers will consent to use the new DNA sample for unspecified genetic testing. 

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