Treatment Naïve Clinical Research Trials

Current clinical trials that are available for treatment-naïve, or newly diagnosed AIDS/HIV patients include the Acute HIV Treatment Study, A5232, A5240, Structured Treatment Interruption Study, and the Kaletra/Truvada versus Kaletra/raltegravir Study. Individual requirements and treatments for each study differ.

Acute HIV Treatment Study

The Acute HIV Treatment Study will administer a once-daily regimen to determine the safety, tolerability, and effectiveness of Truvada and Sustiva in patients with acute HIV infection.

Requirements for this study include:

• Documented negative EIA/WB with +HIV RNA, or
• +p24 Ag within 30 days of screening

Treatment will include:

• Administrations of the drugs Truvada and Sustiva

To become involved, contact Kara McGee:

• Phone: 919-668-0242
• E-mail: mcgee018@mc.duke.edu

A5232 - Optimizing Vaccine Responsiveness

Pilot study investigating the extent of immune defects in people who have Hep C, HIV, or both by evaluating immune response to tetanus, Hep A and B antibodies.

Requirements for this study include:

• Treatment naïve
• CD4>300
• Can be co-infected with Hep C virus

Treatment will include:

• Twinrix and diptheria/tetanus immunizations

To participate in this study, contact Jessica Dick, RN:

• Phone: 919-684-9048
• E-mail: jessica.dick@duke.edu

A5240 - HPV Vaccine Study

Safety and immune response to HPV vaccine in HIV+ females.

Requirements for this study include:

• HIV+ female, aged 18-45
• ART naïve, or experienced

Treatment will include:

• All participants will be vaccinated with the HPV recombinant vaccine (Gardasil) by injection

To participate in this study, contact Joan Riddle, RN:

• Phone: 919-668-0175
• E-mail: riddl007@mc.duke.edu

Structured Treatment Interruption

This study will compare the effect of intermittent versus terminal treatment interruption for subjects started on anti-retroviral therapy (ART) during acute infection.

Requirements for this study include:

• Start of ART within 60 days of diagnosis with acute infection
• Six months of ART prior to study entry
• Viral load <200 copies for 90 days prior to study entry

Medications are not provided by study.

To become involved, please contact Kara McGee

• Phone: 919-668-0242
• E-mail: mcgee018@mc.duke.edu

Kaletra/Truvada versus Kaletra/raltegravir Study

Open label comparison study of the safety and tolerability of Kaletra/Truvada versus Kaletra/raltegravir.

Requirements for this study include:

• Treatment naïve

Medications provided.

To become involved, contact Debbie McMullen:

• Phone: 919-668-3759
• E-mail: mcmul006@mc.duke.edu