Table 1.
Details of completed and ongoing human clinical trials of various modalities for HIV prophylaxis [9–25].
| Trial name | Prophylactic modality | Study size | Regimen | Clinical phase | Results |
|---|---|---|---|---|---|
| VAX003 (AIDSVAX B/E) | Recombinant gp120 + alum | 2527 | 7 i.m. Injections over 30 months (dose: 300 μg) | Phase III | No efficacy |
| VAX004 (AIDSVAX B/B) | Recombinant gp120 + alum | 5403 | 7 i.m. Injections over 30 months (dose: 300 μg) | Phase III | No efficacy |
| STEP | Ad5 vector encoding HIV-1 gag, pol and nef genes | 3000 | 3 i.m. Injections (day 0, week 4 and week 26) containing 1.5 × 1010 adenovirus genomes | Phase III | No efficacy |
| RV144 | ALVAC-HIV (canarypox vector expressing HIV-1 gag, protease and gp120) + AIDSVAX (B/E) | 16,395 | 4 i.m. Injections of ALVAC-HIV (day 0, week 4 12 and 24) at the dose of 106.5 TCID50 + 2 i.m. injections of 300 μg AIDSVAX B/E on week 12 and 24 | Phase III | 31.2% protection |
| HVTN 505 | Ad5 vector encoding HIV-1 gag, polgenes and env A, B, C + DNA vaccine encoding nef | 2200 | 3 i.m. Injections of DNA vaccine over 8 weeks + single injection of Ad5 vector on week 24 | Phase II | Results awaited |
| Carraguard® (PC 515) | 3% Carrageenan | 6202 | Vaginal application of 4 ml of 3% Carrageenan gel 1 h before intercourse | Phase III | No efficacy; Carraguard was found to be safe |
| Ushercell | 6% Cellulose sulfate | 1398 | Vaginal application of 3.5 ml of 6% cellulose sulfate gel 1 h before intercourse | Phase III | No efficacy, increased risk of HIV acquisition |
| MDP 301 | 0.5% and 2% PRO 2000 (naphthalene sulfonate polymer) | 9385 | Vaginal application of 0.5% or 2% gel before intercourse | Phase III | No efficacy |
| CAP | 13% cellulose acetate phthalate gel | 6 | Vaginal application of gel | Phase I | Mucosal irritation due to hyperosmolarity |
| MTN 004 | VivaGel (3% SPL7013, dendrimers containing naphthalene sulfonate) end groups | 61 | Twice daily application of 3.5 g VivaGel for 14 days | Phase I | VivaGel was well tolerated although higher incidences of low grade genitourinary adverse effects were observed |
| VivaGel | VivaGel (3% SPL7013) | 11 | One time application of 3.5 g VivaGel | Phase I | Cervicovaginal fluid collected at 3 h after application of VivaGel showed complete inhibition of HIV-1 and cervicovaginal fluid collected at 24 h after application showed 88% protection |
| VOICE 004 | 1% Tenofovir gel | 889 | Vaginal application of 4 ml gel up to 12 h before and after sex | Phase III | 39% Protection; 54% protection in women with high adherence |
| iPrEx | Tenofovir (300 mg) + Emtricitabine (200 mg) (Truvada®) | 2499 (MSM) | Daily oral Truvada® | Phase III | 44% Protection |
| TDF2 | Tenofovir (300 mg) + Emtricitabine (200 mg) (Truvada®) | 1200 | Daily oral Truvada® | Phase III | 63% Protection |
| PIP | Tenofovir (300 mg) + Emtricitabine (200 mg) (Truvada®) or Tenofovir (300 mg) | 4747 | Daily oral Tenofovir or Truvada® | Phase III | 62% Protection for tenofovir group and 73% protection with Truvada® |
| FEM-PrEP | Tenofovir (300 mg) + Emtricitabine (200 mg) (Truvada®) | 1951 | Daily oral Truvada® | Phase III | Trial stopped due to lack of efficacy |
| VOICE | Tenofovir (300 mg) + Emtricitabine (200 mg) (Truvada®) or Tenofovir (300 mg) or 1% tenofovir gel | 5029 | Daily oral Tenofovir or Truvada® or once daily application of 1% tenofovir gel | Phase III | Oral tenofovir and 1% tenofovir gel did not show efficacy |
| IPM 012 | Dapivirine gel | 36 | Once daily vaginal application of two different 0.05% dapivirine gels (2.5 g) for a period of 11 days | Phase I | Dapivirine concentration in cervicovaginal fluid was five logs higher than in vitro IC50 |
| IPM 014A | Dapivirine gel | 280 | Once daily vaginal application of 0.05% dapivirine gel (2.5 g) for 6 weeks | Phase I/II | Ongoing |
| IPM 014B | Dapivirine gel | 100 | Once daily vaginal application of 0.05% dapivirine gel for 6 weeks | Phase I/II | Results awaited |
| IPM 020 | Dapivirine gel | 128 | Once daily vaginal application of two different 0.05% dapivirine gels for a period of 12 weeks | Phase I/II | |
| IPM 013 | Dapivirine (25 mg) vaginal ring | 48 | Group A: dapivirine ring inserted on day 0 and 31 Group B: dapivirine ring inserted on day 0, 38, 59 | Phase I | Peak dapivirine concentrations reached in a day and dapivirine released at a concentration above IC50 for up to 35 days |
| IPM 015 | Dapivirine (25 mg) vaginal ring | 280 | Dapivirine ring inserted once in 28 days over a period of 12 weeks | Phase I/II | Results awaited |
| IPM 027 | Dapivirine (25 mg) vaginal ring | 1650 | N.A. | Phase II | Ongoing |
| MTN 013/ IPM 026 | Maraviroc (100 mg), dapivirine (25 mg) and maraviroc (100 mg) + dapivirine (25 mg) vaginal rings | 48 | Insertion of vaginal ring and checking of drug levels and safety for 28 days | Phase I | Results awaited |
| UC 781 | UC 781 gel | 25 | Twice daily application of 3.5 ml 0.1% or 0.25% UC 781 gel for 14 days | Phase I | Cervicovaginal lavage collected from 13 (out of 15) women treated with 0.25% UC 781 gel showed inhibition of HIV |