Correlation of HIV Levels With Clinical and Immunologic Outcome in Children Treated With Didanosine

NCT00026676 | Completed

• 2 other identifiers: 00013000-C-0130
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Recent studies have shown that patients receiving state-of-the-art treatment for HIV infection (highly active antiretroviral therapy, or HAART) show discordant responses to therapy-that is, they improve both clinically and immunologically (increased CD4 immune cell counts), but their levels of HIV in the blood do not drop. This study will examine blood samples taken from HIV-infected children treated with 2',3'-dideoxyinosine (didanosine, or ddI) in an earlier NCI study to determine if these patients had similar discordant responses to therapy. If so, the study will also examine how these factors may be predictive of disease progression and survival. Investigators will measure HIV levels in blood specimens from children previously enrolled in NCI protocol 88-C-0129. The measurements will be done in specimens drawn before initiation of treatment with ddI and at various times during the course of treatment. The viral responses to therapy will then be correlated with short- and long-term clinical and immunologic outcomes. In addition, researchers will examine these patients' blood samples for additional factors recently discovered to potentially influence disease progression. They include selenium levels and certain genetic factors. A better understanding of discordant responses to therapy will help physicians determine the best treatment option in situations where therapy results do not show uniform benefit. This protocol involves the scientific examination of laboratory specimens only and is not a clinical study open to patient enrollment.

Conditions

HIV Infection

Keywords

Surrogate Markers; Genotypic Resistance; Phenotypic Resistance; Selenium

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Prior enrollment on NCI protocol 88-C-0219, a phase I/II study of 2',3'- dideoxyinosine (ddI) in children with human immunodeficiency virus infection.
• Informed consent for participation in 88-C-0219 clinical trial.
• Adequate available clinical and immunologic data and banked blood specimen components obtained during implementation of the protocol.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Hogg RS, O'Shaughnessy MV, Gataric N, Yip B, Craib K, Schechter MT, Montaner JS. Decline in deaths from AIDS due to new antiretrovirals. Lancet. 1997 May 3;349(9061):1294. doi: 10.1016/S0140-6736(05)62505-6. No abstract available.

  PMID: 9142067 BACKGROUND

• Egger M, Hirschel B, Francioli P, Sudre P, Wirz M, Flepp M, Rickenbach M, Malinverni R, Vernazza P, Battegay M. Impact of new antiretroviral combination therapies in HIV infected patients in Switzerland: prospective multicentre study. Swiss HIV Cohort Study. BMJ. 1997 Nov 8;315(7117):1194-9. doi: 10.1136/bmj.315.7117.1194.

  PMID: 9393221 BACKGROUND

• Palella FJ Jr, Delaney KM, Moorman AC, Loveless MO, Fuhrer J, Satten GA, Aschman DJ, Holmberg SD. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators. N Engl J Med. 1998 Mar 26;338(13):853-60. doi: 10.1056/NEJM199803263381301.

  PMID: 9516219 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 14, 2001
• First Posted: November 15, 2001
• Study Start: May 1, 2000
• Study Completion: April 1, 2003
• Last Updated: March 4, 2008

Record last verified: 2003-04

Locations

US (1)