NCT00051519

Screening HIV-Infected Patients for Vaccine Studies

Completed Last updated 2 July 2017

What this trial tests

trial in HIV Infection in 1,000 participants. Completed in 1 December 2007.

Timeline

9 January 2003

Primary endpoint
1 December 2007

1 December 2007

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,000
Start date	9 January 2003
Primary completion	1 December 2007
Estimated completion	1 December 2007
Sites	1 location across United States

Conditions studied

• HIV Infection — all drugs for HIV Infection →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

18 and older, any sex, with HIV Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This screening study will evaluate potential study volunteers with HIV infection to see if they are suitable candidates for trials of experimental vaccines against HIV (therapeutic), and against other infections (preventive).

* Preventive vaccines against other infections. Preventive vaccines prevent a person from getting a disease. Preventive vaccines have been developed for many diseases, including, for example, whooping cough, measles, mumps, influenza, and hepatitis B. Some preventive vaccines may also prevent a disease from taking hold if given immediately after infection, such as vaccines for rabies, smallpox and hepatitis.
* Therapeutic vaccines against HIV. Therapeutic vaccines are intended to treat someone who has already been infected, with the goal of controlling the disease or preventing it from causing severe illness. As yet, there are no therapeutic vaccines for any diseases.
* Vaccines against other infections. Vaccines to prevent other infections besides HIV may need to be tested separately in people with HIV infection because the immune system works differently when HIV infection is present.

HIV-infected patients 18 years of age or older may be eligible for this screening study. Women who are pregnant or breast feeding may not participate.

Participants will be screened with the following:

* A health history, including questions about sexual activity and drug use;
* Physical examination, including blood and urine tests;
* HIV testing to confirm HIV infection;
* Pregnancy test for premenopausal women;
* PPD test for tuberculosis for those who have not been tested in the previous 6 months.

Candidates who meet the requirements for investigational vaccine studies will be invited to participate in a study. Those who do not begin a study within 1 month of the screening tests may need to repeat some tests for continued consideration. In addition, some studies require repeated measures of CD4 counts and viral load over a period of a few months.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.