Recruiting

Raltegravir & Atazanavir

Sponsor:

Peter J. Ruane, M.D., Inc.

Code:

NCT00751153

Conditions

HIV Infections

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Raltegravir and Atazanavir

Study Details

Brief 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.

Conditions

HIV Infections

Study ID

NCT00751153

Start date

Mar, 2008

Status verified date

Sep, 2008

Completion date

Dec, 2009

Anticipated

Primary completion date

Oct, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Raltegravir and Atazanavir

Rategravir 400 BID, Atazanavir 400 mg daily

Primary outcome measure

  • Evaluation of the proportion of patients who maintain plasma HIV viral load measurements < 400 copies/ml at week 4, 8, 12, 16, 24, 36 and 48 weeks after switching to Raltegravir and Atazanavir [ Time Frame: 48 weeks ]

Central Contacts and Locations

Central contacts

Peter J Ruane, MB

3239541072pjruane@lightsourcemedical.com

Brian Alas

3239541072balas@lightsourcemedical.com

Locations

Medical Practice of Peter Ruane MB

Recruiting

Los Angeles, California, United States, 90036

More Information

Sponsor

Peter J. Ruane, M.D., Inc.

Last update posted

Oct 9, 2008

Last verified

Sep, 2008

Keywords

  • drug substitution
  • Raltegravir
  • Atazanavir
  • treatment Experienced

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Peter J. Ruane, M.D., Inc. on 2008-10-09.