Hydroxychloroquine + Hydroxyurea + ddI

For HIV+ individuals who are looking for an alternative to standard cocktail therapy

 

Background

This study is designed to test a new combination of three medications, of which only one has been approved for treating HIV infection. All 3 drugs are FDA approved for various conditions.

The first drug, Hydroxychloroquine, is routinely prescribed for some arthritic conditions with an excellent safety profile. Hydroxychloroquine reduced HIV viral load, with little drug resistance, in early clinical trials of HIV+ volunteers.

The other two drugs–Hydroxyurea (a cancer drug) and ddI (an anti-HIV drug)–are often prescribed together as components of a larger anti-HIV combination therapy.

Objective
This study compares the safety and effectiveness of the combination of Hydroxychloroquine + Hydroxyurea + ddI.

 

Study Design

A Phase I/II, open-label, 8-week study with a 6-month extension. There is no placebo group–all participants receive drug. Eye exams will be performed during the study. The study has three cohorts (groups):

  • Participants with little prior cocktail therapy ("HAART")
  • Participants whose cocktail therapies have failed and are not currently taking any medications
  • Participants who are currently on an anti-HIV "drug holiday"
Inclusion
Criteria
  • HIV+ man or woman, at least 18 years old.
  • Viral load requirement varies by cohort.
  • T-cell count requirement varies by cohort.
  • Women who are not pregnant and are willing to use contraceptives for the duration of the study.

Status
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Enrolling
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For more information about participation in this study in the Los Angeles area, please call 310/358.2429 or e-mail Corie Castro at ccastro@aidsresearch.org

We encourage participation by women and people of color.

This ad was reviewed and approved by the AIDS Research Alliance Institutional Review Board on August 15, 2000.

 


 

 

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