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Protocol Details

Analysis of HIV-1 Replication During Antiretroviral Therapy

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

08-I-0221

Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Enrolling by Invitation
Gender: Male & Female
Min Age: 18 Years
Max Age: 99 Years

Referral Letter Required

Yes

Population Exclusion(s)

Children

Keywords

HIV;
Natural History;
Natural History

Recruitment Keyword(s)

None

Condition(s)

HIV

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Allergy and Infectious Diseases

This study will determine if the level of virus in HIV-infected patients taking antiretroviral medications for prolonged periods decreases or persists at a stable level. It will also examine whether new gene changes (mutations) occur during drug suppression.

HIV-infected patients who are 18 years of age or older, have been enrolled in another NIH protocol, have been suppressed on antiretroviral therapy and have very low levels of virus in their blood may be eligible for this 5-year (or more) study.

Participants come to the NIH Clinical Center about every 6 months for a physical examination, routine and research blood tests and leukapheresis to collect white blood cells for T cell analysis. For leukapheresis, blood is collected through a vein much like donating whole blood, but the blood is directed through a machine that separates and extracts the white cells and returns the rest of the blood components to the patient. Patients may also have an optional third clinic visit each year for another blood draw.

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Eligibility

INCLUSION CRITERIA:

Inclusion criteria for this protocol comprise all of the following conditions:

- Age greater than or equal to 18 years.

- HIV infection with documented reactive ELISA and positive western blot.

- Prior enrollment in 00-I-0110, 97-I-0082 OR patients with long term evaluation at NIH for whom additional sampling will be useful for protocol objectives, including:

-- Available stored specimens from pretherapy period.

-- Ongoing suppression of viremia with bDNA less than 50 copies/mL, OR

-- Suppression of viremia to less than 50 copies/mL followed by rebound viremia during therapy.

- Patients must have a private physician for routine medical care.

EXCLUSION CRITERIA:

Any prospective study subject who has been previously withdrawn from any prior study for inability to comply with study procedures will be considered ineligible for this study.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Frank Maldarelli, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
NIHBC 10 - CLINICAL CENTER BG RM 2B38
10 CENTER DR
BETHESDA MD 20892
(301) 846-5611
fmalli@mail.nih.gov

Jessica M. Earhart
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 10
Room 2B38A-2
10 Center Drive
Bethesda, Maryland 20892
(240) 858-7504
jessica.earhart@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT00767312

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