Safety, Tolerance, Pharmacokinetic and Antiviral Study of Amdoxovir in Combination With Zidovudine in Adults With HIV

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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 reduced, potentially decreasing side effects, while maintaining antiviral effects.

Study hypothesis: DADP in combination with AZT is safe and effective, and AZT dosing may be reduced, resulting in lower levels of AZT-monophosphate associated with toxicity and maintaining levels of AZT-triphosphate associated with efficacy.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RFS Pharma, LLC
• Treatments: Antiviral Agents; Zidovudine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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