Observational Clinical Research Trials

Currently, there are six clinical trials available for treatment-naïve AIDS/HIV patients: ACTG A5001, Acute HIV Longitudinal Trial, CHAVI 001, CHAVI 012, CHAVI B-cell, Proteinuria, and the True Prevalance Study. All are currently open for enrollment, though the individual requirements and treatments for each study differ.

Acute HIV Longitudinal Trial

The purpose of this observational study is to provide long-term follow up of acutely/recently HIV infected patients.

Requirements for this study include:

• Subjects with a negative antibody test
• A positive HIV viral load within 30 days
• Negative antibody test during the previous 12 months

Treatment will include:

• Observation only; no medicine will be provided during study.

To become involved, contact Kara McGee:

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

CHAVI 001

Chavi 001 is an acute HIV-1 infection prospective cohort study to acquire data for HIV vaccine development.

Requirements for this study include:

• Negative EIA/WB with positive HIV RNA within 30 days prior to study entry.

Treatment will include:

• Observation only.

To become involved, contact Kara McGee:

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

CHAVI 012

Acute infection observation study. One visit with possible follow-up.

Requirements for this study include:

• Acutely diagnosed within six months
• May be treatment naïve or on treatment

Possible procedures compensated by study:

• Colonoscopy with biopsy
• Bone marrow aspirate
• Leukopheresis

To become involved, contact Kara McGee:

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

CHAVI B-Cell

The Chavi B-cell study intends to assess the immune systems of chronically infected patients to inform development of an HIV vaccine.

Requirements for this study include:

• Chronically HIV infected patients
• On or off ARVs.

Treatment will include:

• Observational study; one time blood draw.

To become involved, contact Kara McGee:

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

Proteinuria

The purpose of this observational study is to assess endothelial cell function in HIV infected patients with and without proteinuria.

Requirements for this study include:

• HIV+
• HIV RNA of less than 50
• Age 18-50

Treatment will include:

• Observational study

To become involved, contact Joan Riddle, RN:

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

True Prevalance

Use of current or new genotype testing to detect low level resistance, particularly to NNRTIs that may cause treatment failure or emergence of further resistance.

Requirements for this study include:

• Naïve subjects about to initiate NNRTI and NRTI ART (no PI)
• Baseline genotype shows no NRTI or NNRTI resistance
• Viral load >50,000 copies

This is an observational study.

To become involved, contact Brian Lane, RN, or Lynn McNeil, RN:

• Phone: 919-668-0166 or 919-668-0164
• Email: brian.lane@duke.edu, or donna.mcneil@duke.edu