Status:
COMPLETED
Safety, Tolerance, Pharmacokinetic and Antiviral Study of Amdoxovir in Combination With Zidovudine in Adults With HIV
Lead Sponsor:
RFS Pharma, LLC
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine the short term safety, tolerance, and antiviral effect of zidovudine (AZT) and amdoxovir (AMDX, DAPD) in combination, and whether the dosage for AZT can be re...
Detailed Description
By 2008, market data suggest that the most commonly prescribed initial treatment regimen for HIV-1 will consist of Truvada® (FTC and tenofovir disoproxil fumarate (TDF)) and Sustiva® (efavirenz (EFV))...
Eligibility Criteria
Inclusion
- HIV-infection
- Antiretroviral therapy naïve, or if experienced, no treatment within 90 days of study screening and plan to remain off therapy for the duration of the screening and study treatment period
- HIV-1 RNA ≥ 5,000 copies/mL within 30 days of study Day 1
- CD4+ count ≥ 200 cells/mm³ within 30 days of study Day 1
- Agree to the use of two forms of adequate contraception for women, one form for men
- Estimated creatinine clearance \> 80 mL/min
- Serum creatinine \< 1.5 g/dL
- Able to give written informed consent prior to study start and adhere to study requirements
Exclusion
- Active alcohol or drug use which in the opinion of the Investigator will likely compromise adherence to the study requirements
- A positive urine test for amphetamines, cocaine, and/or opioids
- Currently has any active AIDS defining illness (Category C condition according to the CDC Classification System for HIV Infection 1993)
- Any active clinically significant disease or findings during screening of medical history or physical examination that in the Investigator's opinion would compromise the outcome of the study
- Receiving oral concomitant antiviral or prophylactic drugs for opportunistic infections within 30 days prior to study entry
- Receiving concomitant treatment with nephrotoxic drugs (e.g., aminoglycosides \[tobramycin, gentamicin, and amikacin\], amphotericin B, vancomycin, cidofovir, foscarnet, cis-platinum, pentamidine), or competitors of renal excretion (e.g., probenecid) within 30 days of study entry
- Visual abnormalities (e.g. cataracts, macular degeneration) other than non-organic decreased visual acuity
- Receiving concomitant treatment with immunosuppressive drugs within 30 days prior to study entry
- Diabetes mellitus Type 1 or 2 which is being treated or not with any anti-diabetes agents
- Current significant gastrointestinal, renal, hepatic, bronchopulmonary, biliary, neurological, cardiovascular, oncologic, allergic, or ophthalmologic diseases including history of cataracts/lens opacities
- The following laboratory values performed within 30 days prior to study Day 1:
- Hemoglobin \< 9.0 g/dL for men; 8.0 g/dL for women
- Platelet count \< 75,000 cells per mL
- Absolute neutrophil count \< 1,000 cells per mL
- AST, ALT, alkaline phosphatase, and amylase \> 3 x ULN
- Random or fasting glucose \> 121 mg/dL
- Serum lipase \> 1.5 x ULN
- Urinalysis ≥ 2+ proteinuria and ≥ 2 cellular casts per high powered field (HPF)
- Active acute hepatitis A and/or chronic hepatitis B or C with detectable viremia
- Subjects with clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (INR \> 1.3 or albumin \< 30 g/l or bilirubin \> 2.5 x ULN)
- Pregnant women
- Breastfeeding women
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
End Date :
May 1 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00432016
Start Date
February 1 2007
End Date
May 1 2007
Last Update
May 11 2007
Active Locations (1)
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1
Hospital Privado Modelo
Buenos Aires, Argentina, B1602DBG