Raltegravir Added to Stable HAART in HIV-1 Infected Subjects With Viral Suppression and Low CD4 Recovery

NCT00562510 | Terminated Phase 3 DMC

• 2 other identifiers: FH-RAL-01ANMAT-1-4721846/07-6
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 3, randomized, double blinded, placebo-controlled study designed to compare the safety, tolerability, antiviral activity and immunological effect of raltegravir added to a previously stable HAART regimen in the treatment of HIV-1 infected subjects with undetectable viraemia and low CD4 recovery. HYPOTHESIS: Adding raltegravir to a stable HAART in patients with undetectable plasma viral load and low CD4 recovery will result in further viral suppression and therefore higher CD4 recovery.

Conditions

HIV Infections

Keywords

HIV-1 infection; raltegravir; immune discordance; treatment experienced

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects increasing CD4 count > 50 cells/mm³.

  48 weeks

Secondary Outcomes (6)

• Proportion of patients achieving plasma HIV-RNA < 5 copies/ml.

  48 weeks

• Proportion of subjects increasing CD4 count > 50 cells/mm³.

  24 weeks

• Proportion of patients achieving CD4 count > 250 cells/mm3

  48 weeks

• Proportion of patients achieving an increase of 5 percentual points in CD4 percentage

  48 weeks

• Median change from baseline in CD4 count.

  48 weeks

Study Arms (2)

Raltegravir

EXPERIMENTAL

Drug: Raltegravir

Raltegravir matching placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Raltegravir DRUG

Raltegravir 400 mg BID added to stable HAART

Raltegravir

Placebo DRUG

Placebo BID added to stable HAART

Raltegravir matching placebo

Eligibility Criteria

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

You may qualify if:

• Documented HIV-1 infection.
• Subject has voluntarily signed and dated an informed consent form.
• Documented sustained HIV RNA \< 50 copies/ml (two consecutive pVL \< 50 copies/ml, first VL \> 12 months before the screening date) without documentation of HIV RNA \> 50 copies/ml for at least 12 months while on previous stable HAART (PS\_HAART).
• HIV RNA \< 50 copies/ml at screening.
• Subject is currently receiving an antiretroviral regimen which has not changed for at least 12 months.
• CD4 count \< 200 cells/ mm3 AND CD4 increase \< 100 cells/ mm3 in the last 12 months.
• Subject's vital signs, physical examination and laboratory results do not exhibit evidence of acute illness.
• Negative serum or urine pregnancy test and willing to use acceptable means of contraception.

You may not qualify if:

• Patient is receiving tenofovir DF AND didanosine as a component of the background antiretroviral therapy.
• Patient has a current (active) diagnosis of acute hepatitis due to any cause OR chronic hepatitis B and/or C WITH aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)\>2.5 x upper limit of normal (ULN) AND/OR is likely to require treatment in the next year.
• Subject has significant history of cardiac, renal, neurologic, psychiatric, oncologic, metabolic, or hepatic disease or any condition that, in the investigators opinion, could compromise the subject's safety or adherence to the trial protocol.
• Subject has a currently active AIDS defining illness (category C conditions according to the CDC Classification System for HIV infection 1993) within 30 days of screening. Subjects who are on stable maintenance therapy for an opportunistic infection may be enrolled.
• Life expectancy \< 1 year according to the judgment of the investigator.
• Screening laboratory analysis show any of the following abnormal laboratory results:
• Hemoglobin \< 8.0 g/dL
• Absolute neutrophil count \< 750 cells/µL
• Platelet count \< 50,000 mm3
• Use of any investigational agents within 30 days prior to screening.
• Previous use of integrase inhibitors.
• Use of immunosuppressive drugs, cytokine inhibitors or other cytokines in the last year.
• Continuous use of systemic corticoids for more than a month in the last year or any use in the last 3 months.
• Subject has an ongoing history of substance abuse or psychiatric illness.
• Subject is pregnant or breast-feeding.

Sponsors & Collaborators

• Pedro Cahn: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Fundacion Huesped

Buenos Aires, 1202, Argentina

Location

Related Links

• Fundacion Huesped

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir Potassium

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

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Pedro E Cahn, MD, PhD

  Fundacion Huesped

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 21, 2007
• First Posted: November 22, 2007
• Study Start: August 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 9, 2015

Record last verified: 2015-06

Locations

AR (1)