Integrase Resistance Analysis in HIV Patients Who Interrupted Raltegravir Due to Incomplete Viral Suppression

NCT00787774 | Unknown

• 1 other identifier: RAL-dyn
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective study to evaluate the potential persistent viral effect of raltegravir in 20 treatment experienced HIV patients with incomplete viral suppression

Conditions

HIV Infection

Keywords

HIV; resistance; integrase

Outcome Measures

Primary Outcomes (1)

• Change in viral load after resuming raltegravir in patients with incomplete viral suppression with raltegravir.

  24 weeks

Interventions

resume raltegravir DRUG

resume raltegravir after 16 weeks of stopping

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects on Raltegravir-containing regimen with confirmed virological failure (VL \>500c/mL for \> 3 months).
• Patients treated with a raltegravir-containing regimen for at least for 24 weeks.
• CD4 cell count \> 50 cell/mm3.
• Adherence \>90%, measured by short -self report questionnaire during the 3 months preceding the study entry.
• No reasonable additional therapeutic options

You may not qualify if:

• History or suspicion of alcohol or drug use which in the investigator's opinion would likely compromise subjects' safety and/or study procedures.
• A positive urine drug test for amphetamines, cocaine and opioids at two consecutive screenings (a positive drug test at study screening will be repeated at baseline).
• Life expectancy less than 6 months.
• Subject has any currently active AIDS defining illness (Category C conditions according to the CDC Classification System for HIV Infection 1993) with the following 2 exceptions:
• Stable cutaneous Kaposi's Sarcoma that is unlikely to require any form of systemic therapy during the study period.
• Wasting syndrome due to HIV infection if, in the investigator's opinion, it is not actively progressive.
• Any active clinically significant disease (e.g. TB, cardiac dysfunction) or findings during screening of medical history or physical examination that in the investigator's opinion, would compromise the outcome of the study.
• Pregnant or breast-feeding female.
• Renal impairment: serum creatinine \> 2 x ULN.
• Chronic Hepatitis B or C with ALT or AST \> 3 x ULN.
• Acute Hepatitis A, B or C. Acute Hepatitis A, B or C.
• Any grade 3 or 4 toxicity according to the enhanced ACTG grading severity list, except for grade 3 or 4 asymptomatic triglyceride/cholesterol elevations, isolated grade 3 increased in GGT, grade 3 increases in glucose, asymptomatic grade 3 increases in amylase with no elevation of lipase.
• Currently significant diarrhea, gastric stasis or constipation that in the investigator's opinion could influence drug absorption or bioavailability.
• Subjects with clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (INR \> 1.3 or albumin \< 30g/l or bilirubin \> 2.5 x ULN).

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic

Barcelona, Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jose M Gatell, MD

  Hospital Clinic of Barcelona

  STUDY CHAIR

Central Study Contacts

Jose Luis Blanco, MD

CONTACT

+34932275400

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 7, 2008
• First Posted: November 10, 2008
• Study Start: November 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: March 31, 2010

Record last verified: 2010-03

Locations

ES (1)