Evaluating the Effect of CHanging EnfuvirtidE to Raltegravir in HIV Infected Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00529243
• Date of registration: 12/09/2007
• Primary sponsor: Kaiser Permanente
• Public title: Evaluating the Effect of CHanging EnfuvirtidE to Raltegravir in HIV Infected Subjects CHEER
• Scientific title: Virologic Outcomes of Changing Enfuvirtide to Raltegravir in HIV-1 Patients Well Controlled on an Enfuvirtide Based Regimen
• Date of first enrolment: September 2007
• Target sample size: 52
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00529243
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: William J Towner, MD
• Affiliation: Kaiser Permanente

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients must meet all of the following inclusion criteria to be eligible for
participation in this study.

1. Subject is = 18 years of age and able to understand and willing to sign a
written informed consent form, which must be obtained prior to initiation of the
study.

2. Documented laboratory diagnosis of HIV-1 infection (positive Enzyme-linked
immunosorbent assay (ELISA) HIV-1 antibody test confirmed by western blot, p24
assay, HIV-1 RNA, or culture).

3. Have documented plasma HIV-1 RNA level(s) of < 75 copies/ml by branched
deoxyribonucleic acid(bDNA) assay, or < 50 copies/ml by Ultrasensitive
Polymerase Chain Reaction(PCR) for at least 6 months prior to screening visit.

4. Currently receiving a stable antiretroviral regimen consisting of enfuvirtide
plus at least 2 other antiretrovirals for at least 6 months.

5. Negative serum pregnancy test (females of childbearing potential only) and are
willing to use an adequate method of contraception throughout the duration of
the study.

Exclusion Criteria:

- Patients who meet any of the following exclusion criteria are not to be enrolled in
this study.

1. Any prior therapy with MK-0518 or any other HIV-1 integrase inhibitor.

2. Any HIV-1 viral load > 75 copies/ml by bDNA assay, or > 50 copies/ml by
Ultrasensitive PCR assay in the 6 months prior to screening visit (A single
"blip" of HIV-1 viral load >75 copies but <400 copies by bDNA assay, or >50
copies but <400 copies by Ultrasensitive PCR assay in the six months prior to
screening visit with at least one subsequent HIV-1 viral load below the limit of
detection will be accepted.)

3. Any previous known hypersensitivity to components of the study drug formulation.

4. Weight < 40 kilograms.

5. Patient requires or is anticipated to require any of the prohibited medications
noted in the protocol.

6. Acute therapy for serious illness (in the opinion of the investigator) within 14
days prior to study entry unless the subject has completed = 7 days of therapy
and is considered clinically stable by the investigator.

7. Any condition which, in the opinion of the investigator, would compromise the
subject's ability to participate in the study.

8. Any active opportunistic infections or Centers for Disease Control and
Prevention (CDC) Category C conditions (with the exception of stable cutaneous
Kaposi's Sarcoma and wasting syndrome due to HIV infection).

9. Any malignancy requiring chemotherapy.

10. Subject has any of the following laboratory results at screening:

Hemoglobin < 8.0 gr/dl Absolute neutrophil count < 750 cells/ml Platelet count <
40,000 Creatinine > 2.0 or calculated creatinine clearance < 40 ml/min

11. Female patient who is pregnant or breast-feeding, or expecting to conceive or
donate eggs during the study. Male patient who is planning to impregnate or
provide sperm donation during the study.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: raltegravir

Primary Outcome(s)

Number of Patients With Undetectable Human Immunodeficiency Virus (HIV) Viral Load at Week 24. [Time Frame: 24 Weeks]

Secondary Outcome(s)

Average Change in Cluster of Differentiation 4(CD4) Cell Count From Baseline at Week 24 [Time Frame: 24 Weeks]

Secondary ID(s)

4908

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Merck