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Combination Drug Treatment of Pediatric HIV Infection

2014-08-27 03:59:25 | BioPortfolio

Summary

This study will test the safety and effectiveness of hydroxyurea, an anti-cancer drug, given together with the anti-HIV drugs didanosine, stavudine and efavirenz for treating children infected with human immunodeficiency virus (HIV). Some studies have found that hydroxyurea may help certain anti-HIV drugs to work better and that the virus does not become resistant to it, as it does other drugs. This study will also examine how hydroxyurea affects the body's immune system and virus levels.

Patients 3 through 21 years old with HIV infection may be eligible for this 52-week study. They will be screened for eligibility with a thorough physical examination, including chest X-ray, electrocardiogram and echocardiogram, head CT scan, eye examination and blood tests.

All patients in the study will take didanosine twice a day, stavudine twice a day and efavirenz once a day. All patients will also take hydroxyurea twice a day, but some will take a low dose of the drug, while others will take a high dose. Within each of these two groups (high and low dose) some patients will start taking hydroxyurea the same day they begin the anti-HIV drugs; others will not start hydroxyurea until after they have taken the anti-HIV drugs for 5 weeks. Patients will have a physical examination every 3 weeks until week 12, then every 4 weeks until week 24, and then every 8 weeks until the end of the study. Blood tests to measure virus levels will be done every other day for the first 7 days and periodically after that. For the first 8 weeks after starting hydroxyurea, blood tests will be done weekly. An eye examination, chest X-ray, electrocardiogram, and CT scans of the head will be done about every 6 months.

Description

This is a pilot study to determine the safety, toxicity, virologic and immunologic effects of combination therapy with hydroxyurea, a cytostatic chemotherapeutic agent, two nucleoside reverse transcriptase inhibitors and a non-nucleoside reverse transcriptase inhibitor in children with HIV infection. We will enroll HIV-infected children who have detectable viral loads (greater than 10,000 copies/ml). Patients will be stratified upon enrollment by CD4 cell count (less than or greater than 200 CD4 cells/mm(3)). Two dose levels of hydroxyurea will be utilized (7.5 mg/kg/dose twice daily and 12.5 mg/kg/dose twice daily). It is anticipated that 15 patients will be enrolled at the Low Dose Level and 10 patients at the High Dose Level of hydroxyurea within each CD4 cohort, for a total of 50 patients on study. Within each dose level patients will receive the antiretroviral agents didanosine, stavudine and efavirenz beginning on study Day one and will be randomized to receive hydroxyurea either on Day 1 or week 6. The cohorts will be escalated and analyzed separately. The study duration will be 52 weeks. This study will attempt to define an effective and tolerable dose of hydroxyurea.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Conditions

HIV Infection

Intervention

Hydroxyurea

Location

National Cancer Institute (NCI)
Bethesda
Maryland
United States
20892

Status

Completed

Source

National Institutes of Health Clinical Center (CC)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:59:25-0400

Clinical Trials [362 Associated Clinical Trials listed on BioPortfolio]

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PubMed Articles [6327 Associated PubMed Articles listed on BioPortfolio]

Hydroxyurea responses in clinically varied beta, HbE-beta thalassaemia and sickle cell anaemia patients of Eastern India.

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Real-life experience with hydroxyurea in sickle cell disease: A multicenter study in a cohort of patients with heterogeneous descent.

We conducted the first nation-wide cohort study of sickle cell disease (SCD) in Italy, a Southern European country exposed to intense recent flux migration from endemic areas for SCD. We evaluate the ...

Fibrotic Lung Toxicity Induced by Hydroxycarbamide.

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A patient case highlighting the myriad of cutaneous adverse effects of prolonged use of hydroxyurea.

Hydroxyurea is an antimetabolite primarily used to treat myeloproliferative disorders, and chronic treatment is associated with many cutaneous adverse effects ranging in severity from ichthyosis to ag...

The Roles of P53 and its Family Proteins, P63 and P73, in the DNA Damage Stress Response in Organogenesis Stage Mouse Embryos.

Members of the P53 transcription factor family, P53, P63 and P73, play important roles in normal development and in regulating the expression of genes that control apoptosis and cell cycle progression...

Medical and Biotech [MESH] Definitions

An antineoplastic agent that inhibits DNA synthesis through the inhibition of ribonucleoside diphosphate reductase.

Infection by a variety of fungi, usually through four possible mechanisms: superficial infection producing conjunctivitis, keratitis, or lacrimal obstruction; extension of infection from neighboring structures - skin, paranasal sinuses, nasopharynx; direct introduction during surgery or accidental penetrating trauma; or via the blood or lymphatic routes in patients with underlying mycoses.

A nontuberculous infection when occurring in humans. It is characterized by pulmonary disease, lymphadenitis in children, and systemic disease in AIDS patients. Mycobacterium avium-intracellulare infection of birds and swine results in tuberculosis.

Infection involving the tissues or organs in the PELVIS.

Infection in humans and animals caused by fungi in the class Zygomycetes. It includes MUCORMYCOSIS and entomophthoramycosis. The latter is a tropical infection of subcutaneous tissue or paranasal sinuses caused by fungi in the order Entomophthorales. Phycomycosis, closely related to zygomycosis, describes infection with members of Phycomycetes, an obsolete classification.

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