Clinical trial NCT00031044 (phase 1/phase 2, status: completed)
Conditions: hiv infections
ICD codes: Z21
Drugs: enfuvirtide, amdoxovir
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@H](CC1=CN=CN1)NC(=O)[C@@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(C)=O)[C@@H](C)O)[C@@H](C)CC)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC1=CNC2=C1C=CC=C2)C(=O)N[C@@H](C)C(=O)N[C@@H](CO)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC1=CNC2=C1C=CC=C2)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC1=CNC2=C1C=CC=C2)C(=O)N[C@@H](CC1=CC=CC=C1)C(N)=O, NC1=NC(N)=C2N=CN([C@H]3CO[C@@H](CO)O3)C2=N1
Eligibility criteria:

        Note: Enrollment into this study was permanently closed on 02/09/04.

        Inclusion Criteria:

          -  HIV infected

          -  Taken at least two combination anti-HIV treatments containing three or more drugs. In
             total, the treatments must have lasted at least 24 months and must have included at
             least two nucleoside reverse transcriptase inhibitors (NRTIs), two protease inhibitors
             (PIs), and one nonnucleoside reverse transcriptase inhibitor (NNRTI).

          -  Failed two previous combination treatments of three or more drugs

          -  Viral load of more than 5000 copies/ml on stable (at least 8 weeks) antiretroviral
             regimen, within 60 days prior to study entry

          -  Willing to stay on the current failing anti-HIV treatment until starting study
             treatment; may have to remain on failing regimen for an additional 60 days after study
             screening

          -  Willing to use acceptable methods of contraception

          -  Access to optimized background (OB) regimen drugs

          -  Ability to bring OB regimen drugs to screening visit

        Exclusion Criteria:

          -  Prior use of DAPD or ENF

          -  Drug or alcohol use which, in the opinion of the investigator, would interfere with
             the study

          -  History of any illness that, in the opinion of the investigator, would interfere with
             study participation

          -  Single kidney or history of two or more episodes of kidney stones

          -  Pregnant or breastfeeding

          -  Experimental anti-HIV drug use or use of any agent that acts on the immune system
             within 60 days prior to entry

          -  Active immunization within 21 days prior to study entry

          -  Acute therapy for a serious infection or illness

          -  Active AIDS-defining opportunistic infection requiring acute treatment

          -  Unexplained fever within 7 days prior to study entry

          -  Cancer that requires chemotherapy

          -  Prior HIV vaccination, except for subunit vaccines that contained only gp120

          -  Certain mutations in HIV-1 reverse transcriptase

          -  Measurable loss of vision due to lens opacity

          -  Posterior subcapsular cataract

          -  Cortical cataract of Grade C3 or higher on the Lens Opacities Classification System
             III (LOCS III) scale

          -  Nuclear opalescence Grade NO3 (LOCS III) or higher

          -  Best corrected vision worse than 20/200

          -  Diabetes mellitus. Gestational diabetes is not excluded.