Raltegravir and Atazanavir Replacing Current Suppressive Treatment Because of Side Effects in Current Treatment

• Status: Unknown status
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Subjects with HIV who have viral suppression on current regimen but also have side effects/intolerance will change their current regimen to a combination of Raltegravir and Atazanavir and be monitored for viral and immunological response and quality of life.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peter J. Ruane, M.D., Inc.
• Treatments: Atazanavir Sulfate; Raltegravir Potassium

Criteria

Inclusion Criteria

• History of no PI resistance or antiretroviral failure while receiving a PI.

• On a current antiviral regimen with plasma HIV viral load (VL) < 400 copies/ml for 4 months or longer.

• Intolerance to or toxicity with current or alternative regimen(s) with side effects including but not limited to gastrointestinal, neurological, metabolic, or dysmorphic symptoms and/or dyslipidemia.

• Continuously using the same regimen for 3 months prior to Screening.

• Women of childbearing potential must be willing to use effective method(s) of contraception throughout their study participation and for 30 days following the end of the study (see Section 1.10). -Women who are postmenopausal for at least 2 years, women with total hysterectomy and women with tubal ligation are considered of non-childbearing potential.

• Willing to adhere to the prohibitions and restrictions specified in this protocol.

Exclusion Criteria:

• Use of any drug contraindicated in the current US package insert for Atazanavir or in the investigators brochure for Raltegravir, including PPI inhibitors.

• Use of any investigational drug up to 4 weeks prior to screening.

• Prior or current therapy with Raltegravir.

• Allergy to Raltegravir or Atazanavir

• History of medication non-compliance significant to the study regimen as deemed significant by the investigator.

• Known achlorhydria that would inhibit the absorption of Atazanavir

• Concurrent active chronic Hepatitis B requiring therapy with 3TC, FTC or Tenofovir (entecavir permitted).

• AST or ALT >5 times ULN

• Calculated CrCl < 30 ml/min.

• Female subject who is pregnant or breastfeeding.

• General medical condition that may interfere with the assessments and completion of the trial.