RAL-eve Study: Raltegravir Substitution Study

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00523237
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Duration (Months): 38
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of this study is to:

• Provide raltegravir to subjects with HIV and an undetectable viral load who are experiencing injection site reactions (ISR) to Enfuvirtide,

• Monitor the safety and efficacy of raltegravir, and

• Assess the change in quality of life in patients who have switched from Enfuvirtide to raltegravir

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Raltegravir	N/A

Detailed Description

We enrolled virologically suppressed HIV-1 infected patients with injection site reactions for a switch from enfuvirtide to raltegravir. At baseline, enfuvirtide was switched to raltegravir without additional changes to the antiretroviral regimen allowed. Viral load, T-cells, and toxicity were evaluated at baseline, 2, 4, 12 and 24 weeks. Adherence and injection site reactions were evaluated at baseline, 4, 12 and 24 weeks. The single-copy assay was used to measure HIV RNA levels at screening, baseline and at 12 and 24 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Raltegravir Substitution for Enfuvirtide in Patients Suffering From Injection Site Reactions (ISRs): The Raleve Pilot Study
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Dec 1, 2010

Outcome Measures

Primary Outcome Measures

1. The Percentage of Patients Who Maintain a Viral Load < 50 Copies/ml After Being Switched From Enfuvirtide to Raltegravir [24 weeks]

   evaluate the percent of patients with viral load of <50 copies at week 24 of study after being switched from enfuvirtide to raltegravir

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry.

2. ART for at least 6 months prior to study entry with a regimen that includes enfuvirtide.

3. Self-defined infusion site reaction to enfuvirtide (usually will be painful inflammatory nodules)

4. No change in ART regimen for at least 3 months prior to study entry.

5. CD4+ cell count >50/mm3 at screening (obtained within 60 days prior to study entry).

6. Documentation of HIV-1 RNA below the limit of quantification of an ultrasensitive assay

7. All HIV-1 RNA levels obtained within 6 months prior to study entry are below the limits of quantification on all tests, except as explained above in section 4.1.6 for a single detectable viral load of <50 copies but <200 copies in last 6 months.

8. Laboratory values obtained within 60 days prior to entry:

• Absolute neutrophil count (ANC) >750/mm3

• Hemoglobin >9.0 g/dL for female subjects and>10.0 g/dL for male subjects

• Platelet count >50,000/mm3

• Calculated creatinine clearance (CrCl) >30 mL/min, as estimated by the Cockcroft-Gault equation*

• AST (SGOT), ALT (SGPT), and alkaline phosphatase <5 x ULN

• Total bilirubin <2.5 x ULN. If the subject is taking an indinavir- or atazanavir-containing regimen at the time of screening, total bilirubin <5 x ULN is acceptable.

1. For females of reproductive potential will need a negative serum or urine pregnancy test within 48 hours prior to entry.

2. Men and women age >18 years.

3. Ability and willingness of subject to provide informed consent.

Exclusion Criteria:

1. Unstable clinical condition, such as unstable cardiac disease, or cancer requiring ongoing chemotherapy or radiation therapy, or other medical condition which, in the opinion of the investigator, would preclude a subject from safely undergoing study procedures.

2. Breast-feeding or pregnancy.

3. An opportunistic infection within 60 days prior to entry.

4. Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation.

5. Active drug or alcohol use or dependence that, in the opinion of the Protocol Director, would interfere with adherence to study requirements.

6. Receipt of a non-HIV vaccination within 30 days prior to study entry or plan for receipt of vaccination during the study.

7. Plan to change the background ART within 24 weeks after study entry.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Andrew R Zolopa, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stanford University
• ClinicalTrials.gov Identifier: NCT00523237
• Other Study ID Numbers: RAL-eve study; NCT00627939
• First Posted: Aug 31, 2007
• Last Update Posted: Nov 2, 2011
• Last Verified: Oct 1, 2011

• Additional relevant MeSH terms: HIV Infections; Raltegravir Potassium

Study Results

Participant Flow

Recruitment Details	Fourteen patients, all men, were enrolled.
Pre-assignment Detail	All screened patients were enrolled into the study

Arm/Group Title	Raltegravir
Arm/Group Description	400 mg twice daily
Period Title: Overall Study
STARTED	14
COMPLETED	14
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Raltegravir
Arm/Group Description	400 mg twice daily
Overall Participants	14
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	14 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56 (56)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	14 100%
Region of Enrollment (participants) [Number]
United States	14 100%

Outcome Measures

1. Primary Outcome

Title	The Percentage of Patients Who Maintain a Viral Load < 50 Copies/ml After Being Switched From Enfuvirtide to Raltegravir
Description	evaluate the percent of patients with viral load of <50 copies at week 24 of study after being switched from enfuvirtide to raltegravir
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

With expected man baseline residual viremia of 5 copies/ml and predicted standard deviation of 3 in change of residual viremia, our study was predicted to have 80% power to detect a difference of 2.5 copies/ml in residual viremia with =0.05.

Arm/Group Title	Enfuvirtide Switch to Raltegravir Arm
Arm/Group Description	patients were switched from Enfuvirtide to Raltegravir
Measure Participants	14
Number [percentage]	86

Adverse Events

Arm/Group Title	Raltegravir
Arm/Group Description	400 mg twice daily
All Cause Mortality
	Raltegravir
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Raltegravir
	Affected / at Risk (%)	# Events
Total	0/14 (0%)
Other (Not Including Serious) Adverse Events
	Raltegravir
	Affected / at Risk (%)	# Events
Total	0/14 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.