None listed
Conditions
Brief summary
Saquinavir and Atazanavir are drugs used in combination therapy to treat HIV disease. Saquinavir is currently available in a 200 milligram capsule. Most individuals currently on saquinavir require to take 5 tablets twice a day. In an attempt to reduce this number of pills, a new capsule has been developed containing 500 milligrams of saquinavir. This study will assess: i) blood drug levels in individuals taking both saquinavir formulations, ii) blood drug levels in individuals taking both saquinavir formulations when given with atazanavir, iii) 48 weeks of follow up for individuals receiving the new saquinavir formulation with atazanavir as HIV therapy.
Interventions
This study compares the pharmacokinetic profile of a new saquinavir 500mg formulation to the standard 200mg formulation currently in use. Patients will be sequentially treated with both formulations and pharmacokinetic properties will be measured and compared. This is a 48 week study.
Sponsors
National Centre in HIV Epidemiology and Clinical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
HIV-1 infected individuals. - On stable antiretroviral therapy for at least three months consisting of nucleoside reverse transcriptase inhibitors and protease inhibitorsOR- On stable antiretroviral therapy for at least three months consisting of atazanavir-saquinavir-ritonavir- Undetectable HIV RNA viral load for past three months.
Exclusion criteria
Individuals receiving on non-nucleoside reverse transcriptase inhibitors within the past three months- Individuals currently receiving other enzyme inducing agents (as per - Individuals receiving ritonavir at doses greater than 100 mg bid- Active AIDS defining illnesses- Previously documented intolerance or virological failure to saquinavir- Previously documented intolerance or virological failure to atazanavir- Patients who are co-infected with Hepatitis B and are likely to require, in their clinicians opinion, HBV nucleoside therapy during the study.- Female patients who are pregnant, breastfeeding, or who plan to become pregnant during the study- Any current clinical or laboratory parameter of ACTG Grade 4 (except lipids & CK)- Evidence of ongoing alcohol and/or drug or substance abuse that would result in the patient being unreliable in fulfilling the conditions of this protocol- Prior non-adherence to antiretroviral treatment regimens that would result in the patient being unreliable in fulfilling the conditions of this protocol- Evidence of active opportunistic infection, intercurrent illness, drug toxicity or any other condition that would preclude the patient from taking the prescribed antiretroviral regimen- Conditions that might interfere with evaluation of the disease under study.- Conditions/allergies that may compromise the safety of the patient.
Outcome results
None listed