HIV-1 infection
Conditions
Interventions
Trade Name: Combivir
Product Name: Combivir
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: lamivudine
CAS Number: 134678-1
Sponsors
IATEC B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - HIV-1 infected patients. - At least 18 years of age. - Males or non-pregnant, non-lactating females. - Treatment for over two years with a first-line regimen of zidovudine plus lamivudine (as either a fixed dose combination or dosed separately) plus either an NNRTI or a (boosted) PI. Patients may have previously used multiple drugs from both the NNRTI or the PI classes. - Plasma HIV-1 RNA levels =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Prior treatment with an NRTI other than zidovudine or lamivudine. - Use of a triple NRTI antiretroviral regimen or a regimen including unboosted saquinavir, fusion inhibitors or hydroxyurea - Prior virological treatment failure, defined as having had to switch to antiretroviral therapy because of virologic failure in the opinion of the physician. - HIV-2 co-infection. - Renal impairment and/or use of nephrotoxic agents which in the opinion of the investigator are a contraindication for the use of tenofovir disoproxil fumarate. - Clinically relevant laboratory abnormalities: anemia, trombocytopenia, leucopenia, elevated liver transaminases, elevated bilirubin, elevated amylase, elevated lipase. - Use of co-medication, other than antiretroviral drugs, with a known pharmacological interaction with one or more of the study drugs - Active alcohol or drug use, sufficient in the investigator’s opinion to prevent compliance with the dosing schedule and evaluations (methadone and buprenorphine use is allowed, although the dose of methadone might need to be adjusted). - Anticipated non-compliance with the protocol. - Presence of a newly (within 30 days prior to the time of enrolment) diagnosed HIV-related opportunistic infection or condition which may interfere with the ability to comply with the study. - Chronic active viral hepatitis or other chronic liver disease, which in the opinion of the investigator is a contraindication for the use of any of the study drugs. - Women who have the intention to become pregnant during the study period. - Patients who have received within 4 weeks prior to entry, or who have an anticipated need for treatment with radiation therapy or cytotoxic chemotherapeutic agents during the protocol study period. - Patients who have taken any investigational drug 30 days prior to the start of the study - Patients with malabsorption syndrome or other gastrointestinal dysfunction which may interfere with drug absorption or prevent the patient from taking oral medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Antiretroviral regimens containing emtricitabine plus tenofovir disoproxil fumarate might be associated with a lower incidence and severity of lipoatrophy. In this study we compare the effect of proactively switching zidovudine and lamivudine to emtricitabine plus tenofovir disoproxil fumarate on peripheral fat loss with continued lamivudine and zidovudine-based treatment in HIV-1 infected adults also receiving a non-nucleoside reverse transcriptase inhibitor or (boosted) protease inhibitor. In the patients who discontinue the use of zidovudine and switch to emtricitabine and tenofovir disoproxil fumarate we expect to demonstrate a regaining or at least a lack of further loss of peripheral adipose tissue. Primary Objective: to compare the changes in limb fat between the 2 study arms. ; Secondary Objective: - To compare the changes in other aspects of body fat distribution, i.e. fat loss, fat gain, as well as in markers of lipid and glucose metabolism, between the 2 study arms. - To compare changes between arms in prevalence of lipodystrophy and lipodystrophy severity according to the Lipodystrophy Case Definition Score (LDCD) - To compare changes in bone mineral density between the 2 study arms - To compare the virologic efficacy between the 2 study arms. - To compare the overall safety between the 2 study arms. ; Primary end point(s): Difference between the continuation arm and the switch arm in changes in limb fat over 48 weeks as measured by whole body DEXA. | — |
Countries
Finland, Spain, United Kingdom
Outcome results
None listed