Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00772902
Other study ID # GS-EU-164-0206
Secondary ID 2008-002043-16
Status Completed
Phase Phase 4
First received October 13, 2008
Last updated November 18, 2011
Start date October 2008
Est. completion date October 2009

Study information

Verified date November 2011
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

This study investigated whether human immunodeficiency virus type 1 (HIV-1) infected subjects with raised cholesterol switching their nucleoside reverse transcriptase inhibitor (NRTI) backbone from Kivexa (Epzicom) to Truvada had an improvement in their fasting total cholesterol after 12 weeks of treatment. The study also investigated whether any improvement had a beneficial effect on the overall cardiovascular risk.


Description:

This was a Phase 4, open-label, randomized, multicenter (in the European Union), controlled study to assess the effect on lipid profile of switching from a stable highly active antiretroviral therapy (HAART) regimen of Kivexa + Kaletra to Truvada + Kaletra in adult HIV-1 infected subjects with raised cholesterol.


Recruitment information / eligibility

Status Completed
Enrollment 85
Est. completion date October 2009
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- = 18 years old

- Plasma HIV-1 RNA < 50 copies/mL at screening and for = 12 weeks prior to Screening

- Stable HAART regimen of Kivexa + Kaletra for = 24 weeks prior to Screening

- Documented confirmed raised total cholesterol = 5.2 mmol/L (= 200 mg/dL) for the last two consecutive tests (at least 4 weeks apart)

- Fasted total cholesterol = 5.2 mmol/L (= 200 mg/dL) at Screening

- Subject willing to continue current unmodified HAART for 12 weeks if randomized to Group 2

- Subjects requiring concomitant lipid regulating therapy must be established on a stable dose/frequency = 12 weeks prior to Screening and be expected to remain stable in dose and frequency throughout the treatment phase of the study. Simvastatin and lovastatin are not allowed.

- Adequate renal function by calculated creatinine clearance = 60 mL/min according to the Cockcroft-Gault formula

- Negative serum pregnancy test (females of childbearing potential only i.e., not surgically sterile or at least 2 years post-menopausal)

- Serum Total Bilirubin = 1.5 mg/dL (Note: In cases of clinically insignificant, asymptomatic elevated Serum Total Bilirubin [e.g. due to Gilbert Syndrome] the subject may be enrolled in the study with Serum Total Bilirubin >1.5 mg/dL with the agreement of the Medical Monitor)

- Women of childbearing potential (WOCBP) must be using a highly effective method of contraception to avoid pregnancy throughout the study and for up to 30 days after the last dose of study drugs in such a manner that the risk of pregnancy is minimized

- Female subjects who are postmenopausal for less than 2 years are required to have follicle stimulating hormone (FSH) = 40 mIU/mL. If the FSH is < 40 mIU/mL, the subject must agree to use highly effective method of birth control to participate in the study.

- Male subjects who are sexually active must be willing to use effective barrier contraception (e.g. condom with spermicide) during heterosexual intercourse from screening through completion of the study and continuing for up to 30 days after the last dose of study drugs

- Life expectancy = 1 year

- The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.

Exclusion Criteria:

- Pregnant or lactating subjects

- Previous treatment with emtricitabine (FTC), tenofovir DF (TDF) or adefovir dipivoxil (ADV)

- Known hypersensitivity to emtricitabine (FTC), tenofovir DF (TDF), Truvada or any of the excipients (e.g., lactose monohydrate)

- Documented resistance to any of the study drugs (either genotypic or phenotypic)

- Severe hepatic impairment

- Hepatitis B infection with viral load > 1000 copies/mL at Screening or Hepatitis C infection requiring therapy

- Treatment with any interferon or pegylated interferon within 18 months prior to Screening

- Hepatic transaminases (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) = 5 × upper limit of normal (ULN)

- Subjects receiving ongoing therapy with any of the medications that are contraindicated with any of the study drugs. Administration of any of these medications must be discontinued at least 28 days prior to the Baseline visit and for the duration of the study period.

- Active, serious infections (other than HIV infection) requiring parenteral antibiotic therapy within 15 days prior to screening

- Prior history of significant renal or bone disease

- Any current known clinical or symptomatic laboratory parameter of Gilead Sciences, Inc., Grade 4. Asymptomatic Grade 4 abnormalities will be permitted at the discretion of the investigator if deemed clinically appropriate (excluding adverse events and laboratory parameters mentioned elsewhere in the inclusion/exclusion criteria). Abnormalities deemed insignificant by the investigator must be discussed with the Medical Monitor prior to enrollment.

- Malignancy other than cutaneous Kaposi sarcoma (KS) or basal cell carcinoma. Subjects with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of baseline and are not anticipated to require systemic therapy during the study

- Current alcohol or substance use judged by the investigator to potentially interfere with subject study compliance

- Subjects currently taking part in any other clinical trial using an investigational product, with the exception of studies where the treatment studied has been stopped for more than 1 month prior to baseline

- Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Truvada + Kaletra
Truvada (emtricitabine 200 mg/tenofovir DF 300 mg)once daily for oral administration according to prescription information. As third agent, continuing Kaletra (lopinavir 200 mg/ritonavir 50 mg) for oral administration according to prescription.
Kivexa + Kaletra
Continuing Kivexa (abacavir sulfate 600 mg/lamivudine 300 mg) once daily for oral administration according to prescription. As third agent, continuing Kaletra (lopinavir 200 mg/ritonavir 50 mg) for oral administration according to prescription.

Locations

Country Name City State
Austria Gilead Sciences Vienna
Germany Gilead Sciences Munich
Italy Gilead Sciences Milan
Spain Gilead Sciences Madrid

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Countries where clinical trial is conducted

Austria,  Germany,  Italy,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary objective is to determine if switching the NRTI backbone from Kivexa to Truvada leads to a reduction in fasting total cholesterol at 12 weeks. 12 weeks No
Secondary Evaluation of fasting metabolic parameters (e.g. LDL, HDL, non-HDL cholesterol, triglycerides and cholesterol ratios). 12 weeks No
Secondary Evaluation of efficacy and safety by assessing adverse events, clinical laboratory tests, physical examinations and vital signs at every visit. Upto 12 weeks No
Secondary Evaluation of changes in the 10-year risk factor for coronary heart disease outcomes as measured by total cholesterol, HDL, blood pressure, smoking status, treatment for hypertension, sex, and age. 10 year risk factor from 12 week evaluation No
See also
  Status Clinical Trial Phase
Completed NCT01968551 - Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults Phase 3
Terminated NCT03708289 - Body Composition, Bone Health and Hormonal Status in HIV-1-infected Individuals
Completed NCT02547844 - Evolution of Plasma Lipid Profile in Patients With HIV1 Who Change Atripla to Eviplera Compared to Continue With Atripla Phase 4
Terminated NCT01345630 - Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With CCR5 Tropic HIV 1 Phase 3
Terminated NCT01173276 - Intrauterine Insemination In HIV-Discordant Couples N/A
Completed NCT00807443 - Effect Of An Integrase Inhibitor On The Latency And Reservoir Of HIV-1 Phase 2
Completed NCT01140139 - Dermal HIV-1 Immunization During Anti-retroviral Therapy Followed by Repeated Treatment Interruptions Phase 1
Withdrawn NCT00340223 - HLA-B35 Alleles and AIDS N/A
Completed NCT00097006 - Retrovirus Epidemiology Donor Study-II (REDS-II) N/A
Completed NCT02217904 - A Study of Islatravir (MK-8591) in Anti-Retroviral Therapy-Naive, Human Immunodeficiency Virus-1 Infected Participants (MK-8591-003) Phase 1
Completed NCT04006704 - Study to Assess the Acceptability of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed-Dose Combination (FDC) Tablets in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Pediatric Participants, Using Matching Placebo Tablets Phase 1
Terminated NCT03060629 - A Study to Assess the Efficacy of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-Adjuvanted Clade C gp140 in Preventing Human Immunodeficiency Virus (HIV) -1 Infection in Women in Sub-Saharan Africa Phase 2
Recruiting NCT00981695 - Safety and Immunogenicity Study of Candidate HIV-1 Vaccine Given to Healthy Infants Born to HIV-1-infected Mothers Phase 1/Phase 2
Completed NCT01084343 - Investigation of the Safety of an HIV-1 Vaccine Given Intra-muscularly and Intra-nasally to Healthy Female Subjects Phase 1
Completed NCT00982579 - Safety and Immunogenicity Study of Candidate HIV-1 Vaccine Given to Healthy Infants Born to HIV-1/2-uninfected Mothers Phase 1
Completed NCT00665847 - TMC125-TiDP35-C213: Safety and Antiviral Activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents Phase 2
Completed NCT00098293 - Trial of Maraviroc (UK-427,857) in Combination With Zidovudine/Lamivudine Versus Efavirenz in Combination With Zidovudine/Lamivudine Phase 3
Completed NCT05944848 - A Study of CL-197 Capsules in Healthy Participants Phase 1
Completed NCT00479999 - Phase 1 Safety Study of Two Experimental HIV Vaccines Phase 1
Completed NCT01192035 - PI or NNRTI as First-line Treatment of HIV in West Africa - the PIONA Trial Phase 4