Antiretroviral Drug Interaction Study in Volunteers With HIV

This is an interventional treatment trial for HIV focused on measuring Atovaquone, Drug Interaction, Pharmacokinetics, Efavirenz, Atazanavir-Ritonavir, HIV Read More

• INCLUSION CRITERIA:

A subject will be considered eligible for this study only if all of the following criteria are met:

1. Between the ages of 18 and 70 years.
2. HIV-infected patients stabilized (greater than or equal to 90 days) on ARV regimens containing efavirenz 600 mg daily, or atazanavir/ritonavir 300/100 mg daily or HIV-infected patients not receiving ARV therapy.
3. CD4 cells greater than or equal to 350 cells/mm3 for HIV-infected patients not receiving ARV therapy.
4. CD4 cells >200 cells/mm3 for HIV-infected patients receiving ARV therapy.
5. Virologically suppressed patients receiving ARV therapy (<200 copies/mL on at least 2 consecutive occasions, within 6 months prior to enrollment).
6. Females of child bearing potential who are able and willing to prevent pregnancy by (a) practicing abstinence or (b) using effective methods of birth control, such as condoms, during the study period and for 1 month after study completion.
7. Subject agrees to storage of specimens for future research.

EXCLUSION CRITERIA:

A subject will be ineligible for this study if 1 or more of the following criteria are met:

1. Concomitant routine therapy with any prescription, over-the- counter, herbal, or holistic medications that are known or suspected to alter atovaquone including rifampin, rifabutin, and metoclopramide for 14 days prior to study participation.
2. Subjects receiving primary or secondary prophylaxis for PCP or toxoplasmosis.
3. ARV regimens containing both EFV and ATV/r.
4. Subjects receiving hormonal contraceptives within 90 days of Study Day 1.
5. Inability to obtain venous access for sample collection.

6. Laboratory and/or physical evidence of any active opportunistic infection.

   Diabetes mellitus requiring treatment with insulin, active tuberculosis, cardiac disease (uncontrolled hypertension and/or heart failure etc.), renal disease (chronic or acute renal failure or insufficiency resulting in baseline serum creatinine greater than 1.5 times upper limit of normal [ULN]), untreated/uncontrolled thyroid disease, untreated/uncontrolled psychiatric disease, active hepatitis (liver failure resulting in liver function tests greater than 3 times the ULN, ascites, or jaundice in the absence of ATV), or any other condition that may interfere with the interpretation of the study results or not be in the best interest of the subject in the opinion of the Investigator.

7. Positive pregnancy test or breastfeeding female.
8. The presence of persistent diarrhea or malabsorption that could interfere with the subject s ability to absorb drugs.
9. Drug or alcohol use that may impair safety or adherence.
10. History of intolerance or allergic reaction (rash; hives; swollen lips; difficulty breathing) to atovaquone.
11. Bleeding disorders (hemophilia, G.I., or intracranial bleeding).
12. Organ transplant recipient.
13. Documented ongoing problems with medication adherence.
14. High likelihood of switching ARV regimen within 12 weeks of the start of the study.